AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
Cardiff University · Academic
In term In term in the September 2026 edition: the latest version runs to 1 December 2028.
- Reference
- DARS-NIC-184980-J5B6C
- Current version
- v9.5
- Term of current version
- 7 August 2024 to 1 December 2028
- Start date
- Before 1 December 2019
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 0
Why the data was released
Objective for processing
Cardiff University requires access to NHS England data for the purpose of the following clinical trial:
AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
The trial formally completed in 2009 and completion was reported to the regulatory authorities. Further follow-up activities took place beyond that completion date but follow-up has since completed. Medicines and Healthcare products Regulatory Agency (MHRA) guidance stipulates that clinical trials should retain data for at least 15 years after completion of the trial. Cardiff University would like to retain this Data for a further 9.5 years beyond the mandatory 15 year period to ensure reconstruction of the trial analysis is possible if required.
No additional data will be requested from NHS England.
This Data Sharing Agreement (DSA) permits processing of the data for the purpose secure storage and back up only.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Cardiff University, contact via the publishing journal or an open letter. In such circumstances, Cardiff University may repeat the previous analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.
Cardiff University may not undertake different analyses to those undertaken during the original analysis.
This DSA does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA maintains a list of all clinical trials registered with them and reserve the right to audit the trial at any point from when the trial is opened to 5 year post trial closure.
A sponsoring organisation and/or the data controller itself may also exercise the right to audit.
This DSA permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, Cardiff University must confirm destruction to NHS England.
If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation Cardiff University must submit an amendment request to NHS England before data is accessed.
Data from the following NHS England datasets will be retained under this Agreement:
- Civil Registration Mortality
- Cancer Registration
- Demographics
The level of the Data being retained will be identifiable – necessary because:
- The data is held in various digital and hard copy archived formats and at multiple physical and cloud-based server and backup server locations by multiple sub-contracted commissioners with delegated data processor responsibilities as described in Section 5 of this Agreement.
- A flatfile extract of the original database was transferred to Cardiff University in 2020 for the sole purpose of supporting any future data and sample sharing under a future amendment of this Agreement.
- The original purpose of data provision was to collect mortality data from participants lost-to-follow. Mortality data provided by NHS England that differed to the data provided by, or that could not be provided by, the recruiting site was entered into the clinical data set. Historical trial records do not evidence exactly which individual data fields were merged for which participants. Therefore, whilst Cardiff University is confident that there is reliance on only a small proportion of the original data set provided to Cardiff University by NHS England under this Agreement, the exact level of reliance is unclear, and deletion of data that did not contribute to the final dataset is not practical or possible.
The Data was minimised prior issue as follows:
- Limited to data for a study cohort identified by, and provided to NHS England, by Cardiff University ; cohort size 2,754 participants registered to the AML15 trial : trial ID, NHS number, forename, surname, initials, address, postcode, and date of birth;
- Limited to data between 2006 and 2017;
- Limited to the following participant geographic areas: England and Wales
No further minimisation of data is proposed due to the reasons described above. The data is embargoed and stored under restricted access following Cardiff University data protection policies and procedures, such that when the means likely reasonably used to attempt to (directly or indirectly) identify an individual from the data are taken into account, the identifiability risk has been reduced to sufficiently remote (unlikely); thus the identifiable risk has been reduced to a level equivalent to if the data were effectively anonymised.
Cardiff University is the research Sponsor and sole data controller for the data provided by NHS England, as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data provided under this DSA and the GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
The funding is provided by Cardiff University. The funding is specifically for the trial described.
University of Birmingham is a processor acting under the instructions of Cardiff University. University of Birmingham's role was limited to providing clinical trial management prior to closure of the trial. The trial master file was transferred from the University of Birmingham to Cardiff University following trial closure. Birmingham University hold the original database for regulatory archiving purposes.
Microsoft Limited (Azure) provides cloud server back up services to Cardiff University and will store copies of electronic data held on Cardiff University Servers, as contracted by Cardiff University.
Cardiff University has outsourced long term archiving of the hard copy Trial Master File to DeepStore Limited.
Processing activities
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).
The Data was previously provided to the University of Birmingham and a copy was subsequently transferred to Cardiff University.
The Data contains directly identifying data items including Names, NHS Number, Date of Birth, Postcode and Gender which are required because the original purpose of data provision was to collect mortality data from participants lost-to-follow. Mortality data provided by NHS England that differed to the data provided by, or that could not be provided by, the recruiting site was entered into the clinical data set. Historical trial records do not evidence exactly which individual data fields were merged for which participants. Therefore, whilst Cardiff University is confident that there is reliance on only a small proportion of the original data set provided to Cardiff University by NHS England under this Agreement, the exact level of reliance is unclear, and deletion of data that did not contribute to the final dataset is not practical or possible.
No additional data will be disseminated by NHS England for the purposes of this DSA.
This DSA permits processing of the data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
This DSA does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA).
The Data will be stored on servers at Cardiff University and at the University of Birmingham respectively.
Cardiff University uses offsite back-up services provided by Deepstore Ltd.
Cardiff University stores Data on the Cloud provided by Microsoft Azure.
In the event that the Data needed to be accessed for the purposes of audit or to enable verification of previous findings, the dataset would be transferred back to the Cardiff University servers with authorisation from the Principal Investigator where it can be accessed by the study statistician only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.
The Data may not be transferred to any other location and may only be accessed by substantive employees of Cardiff University or University of Birmingham for the purposes described above.
This DSA is required for the following reasons;
(1) The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit;
An audit may be required during the period of this agreement. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.
(2) Further analysis is expected on these datasets in future;
Any further analysis will only take place following an amendment to this Agreement that would allow further processing of the data.
(3) Clinical trial data needs to be retained and accessible for 15 years after trial completion. In the case of this trial, the minimum 15 year period was reached in 2024 as the trial completed in 2009. However, participants were followed up and data cleaned and the database locked after this date. The trial assigned a data retention date 9.5 years beyond the mandated 15 year archiving end date, aligned to the date upon which all paediatric participants would have reached maturity to adulthood (based on date of birth) should they remain alive up to that point (i.e. age 16 - December 2028). The purpose being to support long-term patient safety should issues arise in other clinical trials meriting long term regulatory audit and/or follow up of AML15 participants. It would have been difficult to assign and manage different data retention end dates for the separate adult and paediatric and individual IMP treatment populations due to the data being combined in a single dataset. Thus, December 2028 was assigned across the board for all AML15 participant data retention.
Expected output
The AML15 trial was supported by the NIHR Cancer Clinical Research Network and is registered on the NIHR CRN study portfolio (CPMS study ID TBC), and the EudracT (ID: 2005-001149-40) and ISRCTN (ID: ISRCTN11036523) clinical trial registries. Results from the AML15 trial were used alongside the results of the AML16 trial adult only trial to further refine treatments and new trial designs in this patient population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with the same condition to AML15 but different patients), has been based on emerging results from the AML15 trial. AML17 is closed to recruitment with the results published and intervention monitoring ongoing. The AML19 trial is actively recruiting, with closure and results publication planned 2023 onwards. The benefits of individual researchers within the immediate AML study team and wider UK-wide and international AML researchcommunities are multiple scientific and lay results publications. Benefits also include multiple international conference abstract and oral presentations for AML15 and related AML studies (for example AML17 interim results). Following the analyses of the data, the following outputs were produced:
1. AML15 results publication: Burnett et al. (2011). Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab
ozogamicin: results of the MRC AML15 trial. Journal of Clinical Oncology 29(4):369-77. doi: 10.1200/JCO.2010.31.4310. Epub 2010 Dec 20. PMID: 21172891 DOI: 10.1200/JCO.2010.31.4310
2. EudraCT results upload: Results form the trial have been uploaded to Eudrac: EudraCT Number 2005-001349-40 - Clinical trial results - EU Clinical Trials Register
3. Lay summary of results published on CRUK website: a. A trial comparing standard chemotherapy with a less intensive approach for acute promyelocytic
leukaemia, with or without gemtuzumab ozogamicin (AML15) | Cancer Research UK
4. Lay summary of results published on CRUK website:A trial comparing different chemotherapy drug combinations with or without Mylotarg for acute myeloid leukaemia (AML15) | Cancer Research UK
5. Lay summary of results published on CTR website: AML15, AML16 - Centre for Trials Research - Cardiff University 5. AML17 results publication: Burnett, AK et al. (2015).
6. A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. Blood, 125 (25): 3878ʹ3885.
The above outputs contained aggregated data with small numbers suppressed in line with the relevant disclosure rules for the datasets processed under this Agreement from which the aggregated data was derived.
No new outputs are expected to be produced using the data under this Agreement.
Expected measurable benefits
This DSA permits the secure retention of the data only for regulatory archiving and data sharing purposes and no other processing. The following provides background information.
The NCRI AML trials sought to improve treatments for patients with acute myeloid leukaemia for over 20 years, supported by the UK NCRI AML Working Group. The measure of benefits, particularly in the younger patient population, is reliant on survival status being followed up for all patients, usually well past the end date of the clinical trial itself. It is important to identify any patients or sub-populations that have benefited from trial treatment and any late effects of the treatment given. The tracking of some patients via NHS England allowed the trial data to include patients that may have been lost to follow up at participating trial centres.
Benefits reported so far
The AML trials have sought to improve treatments for patients with acute myeloid leukaemia (AML) for over 20 years. Previous AML trials looked at the optimal way of delivering standard drug treatments. AML16 (in older patients) alongside AML15 (in patients under the age of 60) were the first trials to look at novel treatments, in particular the drug-linked monoclonal antibody gemtuzumab ozogamicin (GO or Mylotarg).
The data provided under this Agreement allowed the inclusion of participants lost to follow up at participating trial centres in the final study analysis. The main finding of the study was the identification of sub-populations of patients with acute myeloid leukaemia that might in future benefit from the some of the new treatment drugs and regimes under investigation in the AML15 trial. The findings also informed future trial design.
Results from the AML15 trial were used to further refine treatments in this population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with same condition but different patients), has been based on emerging results from the AML15 trial. Patients with APL (a sub-set of AML) have benefited significantly from the emergence of a chemotherapy-free regimen. Further advances have been made in refining the identification of patients suitable (or not) for stem cell transplant.
AML15 demonstrated that for a subgroup of AML called APL, less toxic treatment could be delivered which at the same time improved outcomes. This has led to a change in the standard of care. It also defined the optimal number of courses of treatment to give (4) in younger patients.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| MRIS - Cause of Death Report | Identifiable | Sensitive | Ongoing | Consent (Reasonable Expectation) |
| MRIS - Cohort Event Notification Report | Identifiable | Sensitive | Ongoing | Consent (Reasonable Expectation) |
| MRIS - Flagging Current Status Report | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
| MRIS - Members and Postings Report | Identifiable | Sensitive | One-Off | Consent (Reasonable Expectation) |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 5 versions — earlier versions existed before this site's records begin.
DARS-NIC-184980-J5B6C-v9.5 7 August 2024 to 1 December 2028
- Title
- AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: MRIS - Cause of Death Report; MRIS - Cohort Event Notification Report; MRIS - Flagging Current Status Report; MRIS - Members and Postings Report
What changed from DARS-NIC-184980-J5B6C-v8.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Title | AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15 | |
| Start date | 2024-08-07 | |
| End date | 2028-12-01 | |
| MRIS - Cause of Death Report: common law duty of confidentiality | Consent (Reasonable Expectation) | |
| MRIS - Cohort Event Notification Report: common law duty of confidentiality | Consent (Reasonable Expectation) | |
| MRIS - Flagging Current Status Report: common law duty of confidentiality | Consent (Reasonable Expectation) | |
| MRIS - Members and Postings Report: common law duty of confidentiality | Consent (Reasonable Expectation) |
Objective for processing
This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Cardiff University to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).
Cardiff University requires access to NHS England data for the purpose of the following clinical trial:
The following provides background information.
AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
Mortality and Cancer data were supplied to Cardiff University by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15'
The trial formally completed in 2009 and completion was reported to the regulatory authorities. Further follow-up activities took place beyond that completion date but follow-up has since completed. Medicines and Healthcare products Regulatory Agency (MHRA) guidance stipulates that clinical trials should retain data for at least 15 years after completion of the trial. Cardiff University would like to retain this Data for a further 9.5 years beyond the mandatory 15 year period to ensure reconstruction of the trial analysis is possible if required.
The Medical Research Council (MRC) has for many years run clinical trials in relation to treatment for Leukaemia. The aim of the trials is to find out whether one treatment is better than another. Usually the trials compare one treatment against another and involve most of the hospitals in the United Kingdom. Over the years this approach has led to a steady improvement in treatment.
No additional data will be requested from NHS England.
Following the award of a research grant from the MRC, Cardiff University has led the Acute Myeloid Leukaemia (AML) 15 Trial. This trial took place in over 200 hospitals in the UK and its aim was to compare different treatments at different stages of the treatment of AML.
This Data Sharing Agreement (DSA) permits processing of the data for the purpose secure storage and back up only.
This work is research in the public interest as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
Cardiff University has determined that there are no moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data processed by Cardiff University has been pseudonymised and complies with the ICO's "Anonymisation: managing data protection risk" code of practice.
Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Cardiff University, contact via the publishing journal or an open letter. In such circumstances, Cardiff University may repeat the previous analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.
If the study participant had a common subtype of AML, the study compared different treatments which had been used in hundreds of patients before and were known to be effective but they had never been compared against each other. If information was available from diagnostic tests that a participant's leukaemia was regarded as at high risk of not responding well to the chemotherapy, he/she was eligible for randomisation to receive with the chemotherapy an additional treatment (Mylotarg) with an antibody. The study assessed whether the response in patients could be improved.
Cardiff University may not undertake different analyses to those undertaken during the original analysis.
After the participant had completed the first two courses the study expected their marrow to have returned to normal. The study then went on to compare different treatments to prevent relapse.
This DSA does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA maintains a list of all clinical trials registered with them and reserve the right to audit the trial at any point from when the trial is opened to 5 year post trial closure.
Once the participant had completed four courses of chemotherapy, they may have been asked to enter the last question in the trial. The study aimed to find out whether adding a fifth course of treatment was beneficial. To answer this point, they were asked to agree to a fifth course of chemotherapy.
A sponsoring organisation and/or the data controller itself may also exercise the right to audit.
With the participant's permission, the study stored some excess cells from the blood or bone marrow for use in future research. Participants received separate information about this additional treatment and were asked to consent.
This DSA permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, Cardiff University must confirm destruction to NHS England.
The AML-15 trial was designed for patients between 0 and 60 years with Acute Myeloid Leukaemia.
If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation Cardiff University must submit an amendment request to NHS England before data is accessed.
Treatment choice and outcome were substantially decided by age. The trial found that patients under 60 years have a significantly higher chance of survival with this treatment. Of patients over 60 years, who were treated intensively over the previous 15 years, there was little evidence of improvements in survival, with Complete Response (CR) rates not improved beyond 60% and relapse in 85% of patients. Large groups of patients over 60 years are not considered fit for intensive treatment - median survival is 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients over 60 years who are not catered for in most trials. Haematology Clinical Trials Unit (HCTU) based at Cardiff University used the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.
Data from the following NHS England datasets will be retained under this Agreement:
The AML15 trial was approved by the regulatory authority and research ethics committees across the UK and beyond between 2005 and 2008. Funding for the trial design was provided by Cancer Research UK and the trial was supported by the NIHR Acute Myeloid Leukaemia Working Group. The trial was formally closed to new patients in 2009 and end of trial was reported to regulatory authorities in 2012.
- Civil Registration Mortality
A total of 2,754 participants are currently involved in this study ranging from ages 0 - 60 years at the time of recruitment for participants under the age of 16 at the time of recruitment their parents/guardians consented on their behalf.
- Cancer Registration
At this stage, the only requirement for accessing ongoing survival data from NHS Digital is to comply with ongoing regulatory requirements from both REC & MHRA for oversight of trial participants.
- Demographics
As the study sponsor, Cardiff University is the sole data controller and processor for the data received from NHS Digital.
The level of the Data being retained will be identifiable – necessary because:
The University of Birmingham's Birmingham Clinical Trials Unit (BCTU) was previously involved as manager of the main trial database. University of Cardiff had confirmed Birmingham Clinical Trials Unit (BCTU) no longer had access to any of the data and consequently it was removed from a previous iteration of this agreement as a named data processor. Cardiff University have since confirmed that BCTU still retain a copy of the dataset.
- The data is held in various digital and hard copy archived formats and at multiple physical and cloud-based server and backup server locations by multiple sub-contracted commissioners with delegated data processor responsibilities as described in Section 5 of this Agreement.
- A flatfile extract of the original database was transferred to Cardiff University in 2020 for the sole purpose of supporting any future data and sample sharing under a future amendment of this Agreement.
- The original purpose of data provision was to collect mortality data from participants lost-to-follow. Mortality data provided by NHS England that differed to the data provided by, or that could not be provided by, the recruiting site was entered into the clinical data set. Historical trial records do not evidence exactly which individual data fields were merged for which participants. Therefore, whilst Cardiff University is confident that there is reliance on only a small proportion of the original data set provided to Cardiff University by NHS England under this Agreement, the exact level of reliance is unclear, and deletion of data that did not contribute to the final dataset is not practical or possible.
The Data was minimised prior issue as follows:
- Limited to data for a study cohort identified by, and provided to NHS England, by Cardiff University ; cohort size 2,754 participants registered to the AML15 trial : trial ID, NHS number, forename, surname, initials, address, postcode, and date of birth;
- Limited to data between 2006 and 2017;
- Limited to the following participant geographic areas: England and Wales
No further minimisation of data is proposed due to the reasons described above. The data is embargoed and stored under restricted access following Cardiff University data protection policies and procedures, such that when the means likely reasonably used to attempt to (directly or indirectly) identify an individual from the data are taken into account, the identifiability risk has been reduced to sufficiently remote (unlikely); thus the identifiable risk has been reduced to a level equivalent to if the data were effectively anonymised.
Cardiff University is the research Sponsor and sole data controller for the data provided by NHS England, as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data provided under this DSA and the GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
The funding is provided by Cardiff University. The funding is specifically for the trial described.
University of Birmingham is a processor acting under the instructions of Cardiff University. University of Birmingham's role was limited to providing clinical trial management prior to closure of the trial. The trial master file was transferred from the University of Birmingham to Cardiff University following trial closure. Birmingham University hold the original database for regulatory archiving purposes.
Microsoft Limited (Azure) provides cloud server back up services to Cardiff University and will store copies of electronic data held on Cardiff University Servers, as contracted by Cardiff University.
Cardiff University has outsourced long term archiving of the hard copy Trial Master File to DeepStore Limited.
Processing activities
Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).
The following provides background information.
The Data was previously provided to the University of Birmingham and a copy was subsequently transferred to Cardiff University.
Identifiable data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at Cardiff University of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in March 2017.
The Data contains directly identifying data items including Names, NHS Number, Date of Birth, Postcode and Gender which are required because the original purpose of data provision was to collect mortality data from participants lost-to-follow. Mortality data provided by NHS England that differed to the data provided by, or that could not be provided by, the recruiting site was entered into the clinical data set. Historical trial records do not evidence exactly which individual data fields were merged for which participants. Therefore, whilst Cardiff University is confident that there is reliance on only a small proportion of the original data set provided to Cardiff University by NHS England under this Agreement, the exact level of reliance is unclear, and deletion of data that did not contribute to the final dataset is not practical or possible.
No additional data will be disseminated by NHS England for the purposes of this DSA.
This DSA permits processing of the data for the purpose of secure storage and back up.
This DSA does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.
This DSA does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA).
The Data will be stored on servers at Cardiff University and at the University of Birmingham respectively.
Cardiff University uses offsite back-up services provided by Deepstore Ltd.
Cardiff University stores Data on the Cloud provided by Microsoft Azure.
In the event that the Data needed to be accessed for the purposes of audit or to enable verification of previous findings, the dataset would be transferred back to the Cardiff University servers with authorisation from the Principal Investigator where it can be accessed by the study statistician only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.
The Data may not be transferred to any other location and may only be accessed by substantive employees of Cardiff University or University of Birmingham for the purposes described above.
This DSA is required for the following reasons;
(1) The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit;
An audit may be required during the period of this agreement. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.
(2) Further analysis is expected on these datasets in future;
Any further analysis will only take place following an amendment to this Agreement that would allow further processing of the data.
(3) Clinical trial data needs to be retained and accessible for 15 years after trial completion. In the case of this trial, the minimum 15 year period was reached in 2024 as the trial completed in 2009. However, participants were followed up and data cleaned and the database locked after this date. The trial assigned a data retention date 9.5 years beyond the mandated 15 year archiving end date, aligned to the date upon which all paediatric participants would have reached maturity to adulthood (based on date of birth) should they remain alive up to that point (i.e. age 16 - December 2028). The purpose being to support long-term patient safety should issues arise in other clinical trials meriting long term regulatory audit and/or follow up of AML15 participants. It would have been difficult to assign and manage different data retention end dates for the separate adult and paediatric and individual IMP treatment populations due to the data being combined in a single dataset. Thus, December 2028 was assigned across the board for all AML15 participant data retention.
Expected output
This Agreement permits the secure retention of the data only and no other processing.
The AML15 trial was supported by the NIHR Cancer Clinical Research Network and is registered on the NIHR CRN study portfolio (CPMS study ID TBC), and the EudracT (ID: 2005-001149-40) and ISRCTN (ID: ISRCTN11036523) clinical trial registries. Results from the AML15 trial were used alongside the results of the AML16 trial adult only trial to further refine treatments and new trial designs in this patient population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with the same condition to AML15 but different patients), has been based on emerging results from the AML15 trial. AML17 is closed to recruitment with the results published and intervention monitoring ongoing. The AML19 trial is actively recruiting, with closure and results publication planned 2023 onwards. The benefits of individual researchers within the immediate AML study team and wider UK-wide and international AML researchcommunities are multiple scientific and lay results publications. Benefits also include multiple international conference abstract and oral presentations for AML15 and related AML studies (for example AML17 interim results). Following the analyses of the data, the following outputs were produced:
No new outputs will be produced under this Data Sharing Agreement
1. AML15 results publication: Burnett et al. (2011). Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab
The following provides background information.
ozogamicin: results of the MRC AML15 trial. Journal of Clinical Oncology 29(4):369-77. doi: 10.1200/JCO.2010.31.4310. Epub 2010 Dec 20. PMID: 21172891 DOI: 10.1200/JCO.2010.31.4310
The data from the AML trials was used for two main purposes:
2. EudraCT results upload: Results form the trial have been uploaded to Eudrac: EudraCT Number 2005-001349-40 - Clinical trial results - EU Clinical Trials Register
1. to contribute to the design of further trials and
3. Lay summary of results published on CRUK website: a. A trial comparing standard chemotherapy with a less intensive approach for acute promyelocytic
2. to potentially update and improve on standard chemotherapy regimens.
leukaemia, with or without gemtuzumab ozogamicin (AML15) | Cancer Research UK
The AML trials group has a history of defining standard of care treatment via the national trials, which have been adopted by the NHS, and have delivered benefit to healthcare systems on that basis.
4. Lay summary of results published on CRUK website:A trial comparing different chemotherapy drug combinations with or without Mylotarg for acute myeloid leukaemia (AML15) | Cancer Research UK
All critical data in relation to AML15 has been published - therefore, these data will not be provided to any further public fora or pharmaceutical collaborators, unless a late safety signal emerges. The follow-on trials, which were informed by the methodology and findings from AML15, have now been designed and are underway. These trials involve different study cohorts and testing of different drugs. Therefore, the data received from NHS Digital covered by this Agreement will not be used to update future trial designs.
5. Lay summary of results published on CTR website: AML15, AML16 - Centre for Trials Research - Cardiff University 5. AML17 results publication: Burnett, AK et al. (2015).
All outputs were aggregated with small numbers suppressed in line with the HES Analysis Guide.
6. A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. Blood, 125 (25): 3878ʹ3885.
The above outputs contained aggregated data with small numbers suppressed in line with the relevant disclosure rules for the datasets processed under this Agreement from which the aggregated data was derived.
No new outputs are expected to be produced using the data under this Agreement.
Expected measurable benefits
This
Agreement
DSA
permits the secure retention of the data only
for regulatory archiving and data sharing purposes
and no other processing.
The following provides background information.
The following provides background information.
The NCRI AML trials sought to improve treatments for patients with acute myeloid leukaemia for over 20 years, supported by the UK NCRI AML Working Group. The measure of benefits, particularly in the younger patient population, is reliant on survival status being followed up for all patients, usually well past the end date of the clinical trial itself. It is important to identify any patients or sub-populations that have benefited from trial treatment and any late effects of the treatment given. The tracking of some patients via NHS England allowed the trial data to include patients that may have been lost to follow up at participating trial centres.
The NCRI AML trials sought to improve treatments for patients with acute myeloid leukaemia for over 20 years, supported by the NCRI AML Working Group. The measure of benefits, particularly in the younger patient population, is reliant on survival status being followed up for all patients, usually well past the end date of the clinical trial itself. It is important to identify any patients or sub-populations that have benefited from trial treatment and any late effects of the treatment given. The tracking of some patients via NHS Digital allows the trial data to include patients that may have been lost to follow up at participating trial centres.
Benefits reported
The AML trials have sought to improve treatments for patients with acute myeloid leukaemia (AML) for over 20 years. Previous AML trials looked at the optimal way of delivering standard drug treatments. AML16 (in older patients) alongside AML15 (in patients under the age of 60) were the first trials to look at novel treatments, in particular the drug-linked monoclonal antibody gemtuzumab ozogamicin (GO or Mylotarg).
The data provided under this Agreement allowed the inclusion of participants lost to follow up at participating trial centres in the final study analysis. The main finding of the study was the identification of sub-populations of patients with acute myeloid leukaemia that might in future benefit from the some of the new treatment drugs and regimes under investigation in the AML15 trial. The findings also informed future trial design.
[1 paragraph unchanged]
AML15 demonstrated that for a subgroup of AML called APL, less toxic
[25 words unchanged]
the optimal number of courses of treatment to give (4) in younger
patients
patients.
DARS-NIC-184980-J5B6C-v8.3 14 December 2021 to 13 December 2022
- Title
- MR826 - AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: MRIS - Cause of Death Report; MRIS - Cohort Event Notification Report; MRIS - Flagging Current Status Report; MRIS - Members and Postings Report
What changed from DARS-NIC-184980-J5B6C-v7.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2021-12-14 | |
| End date | 2022-12-13 |
Objective for processing
This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Cardiff University to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).
The following provides background information.
[1 paragraph unchanged]
This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.
Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required.
The following information provides background information on the purpose of the original study:
[15 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
The study data, including data provided by NHS Digital under previous Agreements, are currently held by Cardiff University. Under this interim extension all devices containing data will be securely stored at Cardiff University's storage address specified in this Agreement.
The following provides background information.
The following provides background on the processing activities undertaken for the original study:
[1 paragraph unchanged]
Expected output
No new outputs will be produced under this Data Sharing Agreement.
This Agreement permits the secure retention of the data only and no other processing.
In any future application, the applicant will be required to provide details of any future outputs planned.
No new outputs will be produced under this Data Sharing Agreement
The following provides background information.
[6 paragraphs unchanged]
Expected measurable benefits
This Agreement permits the secure retention of the data only and no other processing.
The following provides background information.
[1 paragraph unchanged]
In any future application, the applicant will be required to provide details of the expected benefits resulting from the study.
Benefits reported
[1 paragraph unchanged] AML15 demonstrated that for a subgroup of AML called APL, less toxic treatment could be delivered which at the same time improved outcomes. This has led to a change in the standard of care. It also defined the optimal number of courses of treatment to give (4) in younger patients
Objective for processing
This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling Cardiff University to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).
The following provides background information.
Mortality and Cancer data were supplied to Cardiff University by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15'
The Medical Research Council (MRC) has for many years run clinical trials in relation to treatment for Leukaemia. The aim of the trials is to find out whether one treatment is better than another. Usually the trials compare one treatment against another and involve most of the hospitals in the United Kingdom. Over the years this approach has led to a steady improvement in treatment.
Following the award of a research grant from the MRC, Cardiff University has led the Acute Myeloid Leukaemia (AML) 15 Trial. This trial took place in over 200 hospitals in the UK and its aim was to compare different treatments at different stages of the treatment of AML.
This work is research in the public interest as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices.
Cardiff University has determined that there are no moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data processed by Cardiff University has been pseudonymised and complies with the ICO's "Anonymisation: managing data protection risk" code of practice.
If the study participant had a common subtype of AML, the study compared different treatments which had been used in hundreds of patients before and were known to be effective but they had never been compared against each other. If information was available from diagnostic tests that a participant's leukaemia was regarded as at high risk of not responding well to the chemotherapy, he/she was eligible for randomisation to receive with the chemotherapy an additional treatment (Mylotarg) with an antibody. The study assessed whether the response in patients could be improved.
After the participant had completed the first two courses the study expected their marrow to have returned to normal. The study then went on to compare different treatments to prevent relapse.
Once the participant had completed four courses of chemotherapy, they may have been asked to enter the last question in the trial. The study aimed to find out whether adding a fifth course of treatment was beneficial. To answer this point, they were asked to agree to a fifth course of chemotherapy.
With the participant's permission, the study stored some excess cells from the blood or bone marrow for use in future research. Participants received separate information about this additional treatment and were asked to consent.
The AML-15 trial was designed for patients between 0 and 60 years with Acute Myeloid Leukaemia.
Treatment choice and outcome were substantially decided by age. The trial found that patients under 60 years have a significantly higher chance of survival with this treatment. Of patients over 60 years, who were treated intensively over the previous 15 years, there was little evidence of improvements in survival, with Complete Response (CR) rates not improved beyond 60% and relapse in 85% of patients. Large groups of patients over 60 years are not considered fit for intensive treatment - median survival is 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients over 60 years who are not catered for in most trials. Haematology Clinical Trials Unit (HCTU) based at Cardiff University used the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.
The AML15 trial was approved by the regulatory authority and research ethics committees across the UK and beyond between 2005 and 2008. Funding for the trial design was provided by Cancer Research UK and the trial was supported by the NIHR Acute Myeloid Leukaemia Working Group. The trial was formally closed to new patients in 2009 and end of trial was reported to regulatory authorities in 2012.
A total of 2,754 participants are currently involved in this study ranging from ages 0 - 60 years at the time of recruitment for participants under the age of 16 at the time of recruitment their parents/guardians consented on their behalf.
At this stage, the only requirement for accessing ongoing survival data from NHS Digital is to comply with ongoing regulatory requirements from both REC & MHRA for oversight of trial participants.
As the study sponsor, Cardiff University is the sole data controller and processor for the data received from NHS Digital.
The University of Birmingham's Birmingham Clinical Trials Unit (BCTU) was previously involved as manager of the main trial database. University of Cardiff had confirmed Birmingham Clinical Trials Unit (BCTU) no longer had access to any of the data and consequently it was removed from a previous iteration of this agreement as a named data processor. Cardiff University have since confirmed that BCTU still retain a copy of the dataset.
Expected output
This Agreement permits the secure retention of the data only and no other processing.
No new outputs will be produced under this Data Sharing Agreement
The following provides background information.
The data from the AML trials was used for two main purposes:
1. to contribute to the design of further trials and
2. to potentially update and improve on standard chemotherapy regimens.
The AML trials group has a history of defining standard of care treatment via the national trials, which have been adopted by the NHS, and have delivered benefit to healthcare systems on that basis.
All critical data in relation to AML15 has been published - therefore, these data will not be provided to any further public fora or pharmaceutical collaborators, unless a late safety signal emerges. The follow-on trials, which were informed by the methodology and findings from AML15, have now been designed and are underway. These trials involve different study cohorts and testing of different drugs. Therefore, the data received from NHS Digital covered by this Agreement will not be used to update future trial designs.
All outputs were aggregated with small numbers suppressed in line with the HES Analysis Guide.
Benefits reported
Results from the AML15 trial were used to further refine treatments in this population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with same condition but different patients), has been based on emerging results from the AML15 trial. Patients with APL (a sub-set of AML) have benefited significantly from the emergence of a chemotherapy-free regimen. Further advances have been made in refining the identification of patients suitable (or not) for stem cell transplant.
AML15 demonstrated that for a subgroup of AML called APL, less toxic treatment could be delivered which at the same time improved outcomes. This has led to a change in the standard of care. It also defined the optimal number of courses of treatment to give (4) in younger patients
DARS-NIC-184980-J5B6C-v7.3 14 November 2020 to 27 February 2021
- Title
- MR826 - AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: MRIS - Cause of Death Report; MRIS - Cohort Event Notification Report; MRIS - Flagging Current Status Report; MRIS - Members and Postings Report
What changed from DARS-NIC-184980-J5B6C-v6.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-11-14 | |
| End date | 2021-02-27 |
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.
Objective for processing
Mortality and Cancer data were supplied to Cardiff University by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15'
This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.
Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required.
The following information provides background information on the purpose of the original study:
The Medical Research Council (MRC) has for many years run clinical trials in relation to treatment for Leukaemia. The aim of the trials is to find out whether one treatment is better than another. Usually the trials compare one treatment against another and involve most of the hospitals in the United Kingdom. Over the years this approach has led to a steady improvement in treatment.
Following the award of a research grant from the MRC, Cardiff University has led the Acute Myeloid Leukaemia (AML) 15 Trial. This trial took place in over 200 hospitals in the UK and its aim was to compare different treatments at different stages of the treatment of AML.
This work is research in the public interest as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices.
Cardiff University has determined that there are no moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data processed by Cardiff University has been pseudonymised and complies with the ICO's "Anonymisation: managing data protection risk" code of practice.
If the study participant had a common subtype of AML, the study compared different treatments which had been used in hundreds of patients before and were known to be effective but they had never been compared against each other. If information was available from diagnostic tests that a participant's leukaemia was regarded as at high risk of not responding well to the chemotherapy, he/she was eligible for randomisation to receive with the chemotherapy an additional treatment (Mylotarg) with an antibody. The study assessed whether the response in patients could be improved.
After the participant had completed the first two courses the study expected their marrow to have returned to normal. The study then went on to compare different treatments to prevent relapse.
Once the participant had completed four courses of chemotherapy, they may have been asked to enter the last question in the trial. The study aimed to find out whether adding a fifth course of treatment was beneficial. To answer this point, they were asked to agree to a fifth course of chemotherapy.
With the participant's permission, the study stored some excess cells from the blood or bone marrow for use in future research. Participants received separate information about this additional treatment and were asked to consent.
The AML-15 trial was designed for patients between 0 and 60 years with Acute Myeloid Leukaemia.
Treatment choice and outcome were substantially decided by age. The trial found that patients under 60 years have a significantly higher chance of survival with this treatment. Of patients over 60 years, who were treated intensively over the previous 15 years, there was little evidence of improvements in survival, with Complete Response (CR) rates not improved beyond 60% and relapse in 85% of patients. Large groups of patients over 60 years are not considered fit for intensive treatment - median survival is 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients over 60 years who are not catered for in most trials. Haematology Clinical Trials Unit (HCTU) based at Cardiff University used the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.
The AML15 trial was approved by the regulatory authority and research ethics committees across the UK and beyond between 2005 and 2008. Funding for the trial design was provided by Cancer Research UK and the trial was supported by the NIHR Acute Myeloid Leukaemia Working Group. The trial was formally closed to new patients in 2009 and end of trial was reported to regulatory authorities in 2012.
A total of 2,754 participants are currently involved in this study ranging from ages 0 - 60 years at the time of recruitment for participants under the age of 16 at the time of recruitment their parents/guardians consented on their behalf.
At this stage, the only requirement for accessing ongoing survival data from NHS Digital is to comply with ongoing regulatory requirements from both REC & MHRA for oversight of trial participants.
As the study sponsor, Cardiff University is the sole data controller and processor for the data received from NHS Digital.
The University of Birmingham's Birmingham Clinical Trials Unit (BCTU) was previously involved as manager of the main trial database. University of Cardiff had confirmed Birmingham Clinical Trials Unit (BCTU) no longer had access to any of the data and consequently it was removed from a previous iteration of this agreement as a named data processor. Cardiff University have since confirmed that BCTU still retain a copy of the dataset.
Expected output
No new outputs will be produced under this Data Sharing Agreement.
In any future application, the applicant will be required to provide details of any future outputs planned.
The data from the AML trials was used for two main purposes:
1. to contribute to the design of further trials and
2. to potentially update and improve on standard chemotherapy regimens.
The AML trials group has a history of defining standard of care treatment via the national trials, which have been adopted by the NHS, and have delivered benefit to healthcare systems on that basis.
All critical data in relation to AML15 has been published - therefore, these data will not be provided to any further public fora or pharmaceutical collaborators, unless a late safety signal emerges. The follow-on trials, which were informed by the methodology and findings from AML15, have now been designed and are underway. These trials involve different study cohorts and testing of different drugs. Therefore, the data received from NHS Digital covered by this Agreement will not be used to update future trial designs.
All outputs were aggregated with small numbers suppressed in line with the HES Analysis Guide.
Benefits reported
Results from the AML15 trial were used to further refine treatments in this population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with same condition but different patients), has been based on emerging results from the AML15 trial. Patients with APL (a sub-set of AML) have benefited significantly from the emergence of a chemotherapy-free regimen. Further advances have been made in refining the identification of patients suitable (or not) for stem cell transplant.
DARS-NIC-184980-J5B6C-v6.4 1 March 2020 to 13 November 2020
- Title
- MR826 - AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: MRIS - Cause of Death Report; MRIS - Cohort Event Notification Report; MRIS - Flagging Current Status Report; MRIS - Members and Postings Report
What changed from DARS-NIC-184980-J5B6C-v5.5
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-03-01 | |
| End date | 2020-11-13 | |
| MRIS - Cause of Death Report: common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 | |
| MRIS - Cohort Event Notification Report: common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 | |
| MRIS - Flagging Current Status Report: common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 | |
| MRIS - Members and Postings Report: common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.
Objective for processing
Mortality and Cancer data were supplied to Cardiff University by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15'
This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.
Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required.
The following information provides background information on the purpose of the original study:
The Medical Research Council (MRC) has for many years run clinical trials in relation to treatment for Leukaemia. The aim of the trials is to find out whether one treatment is better than another. Usually the trials compare one treatment against another and involve most of the hospitals in the United Kingdom. Over the years this approach has led to a steady improvement in treatment.
Following the award of a research grant from the MRC, Cardiff University has led the Acute Myeloid Leukaemia (AML) 15 Trial. This trial took place in over 200 hospitals in the UK and its aim was to compare different treatments at different stages of the treatment of AML.
This work is research in the public interest as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices.
Cardiff University has determined that there are no moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data processed by Cardiff University has been pseudonymised and complies with the ICO's "Anonymisation: managing data protection risk" code of practice.
If the study participant had a common subtype of AML, the study compared different treatments which had been used in hundreds of patients before and were known to be effective but they had never been compared against each other. If information was available from diagnostic tests that a participant's leukaemia was regarded as at high risk of not responding well to the chemotherapy, he/she was eligible for randomisation to receive with the chemotherapy an additional treatment (Mylotarg) with an antibody. The study assessed whether the response in patients could be improved.
After the participant had completed the first two courses the study expected their marrow to have returned to normal. The study then went on to compare different treatments to prevent relapse.
Once the participant had completed four courses of chemotherapy, they may have been asked to enter the last question in the trial. The study aimed to find out whether adding a fifth course of treatment was beneficial. To answer this point, they were asked to agree to a fifth course of chemotherapy.
With the participant's permission, the study stored some excess cells from the blood or bone marrow for use in future research. Participants received separate information about this additional treatment and were asked to consent.
The AML-15 trial was designed for patients between 0 and 60 years with Acute Myeloid Leukaemia.
Treatment choice and outcome were substantially decided by age. The trial found that patients under 60 years have a significantly higher chance of survival with this treatment. Of patients over 60 years, who were treated intensively over the previous 15 years, there was little evidence of improvements in survival, with Complete Response (CR) rates not improved beyond 60% and relapse in 85% of patients. Large groups of patients over 60 years are not considered fit for intensive treatment - median survival is 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients over 60 years who are not catered for in most trials. Haematology Clinical Trials Unit (HCTU) based at Cardiff University used the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.
The AML15 trial was approved by the regulatory authority and research ethics committees across the UK and beyond between 2005 and 2008. Funding for the trial design was provided by Cancer Research UK and the trial was supported by the NIHR Acute Myeloid Leukaemia Working Group. The trial was formally closed to new patients in 2009 and end of trial was reported to regulatory authorities in 2012.
A total of 2,754 participants are currently involved in this study ranging from ages 0 - 60 years at the time of recruitment for participants under the age of 16 at the time of recruitment their parents/guardians consented on their behalf.
At this stage, the only requirement for accessing ongoing survival data from NHS Digital is to comply with ongoing regulatory requirements from both REC & MHRA for oversight of trial participants.
As the study sponsor, Cardiff University is the sole data controller and processor for the data received from NHS Digital.
The University of Birmingham's Birmingham Clinical Trials Unit (BCTU) was previously involved as manager of the main trial database. University of Cardiff had confirmed Birmingham Clinical Trials Unit (BCTU) no longer had access to any of the data and consequently it was removed from a previous iteration of this agreement as a named data processor. Cardiff University have since confirmed that BCTU still retain a copy of the dataset.
Expected output
No new outputs will be produced under this Data Sharing Agreement.
In any future application, the applicant will be required to provide details of any future outputs planned.
The data from the AML trials was used for two main purposes:
1. to contribute to the design of further trials and
2. to potentially update and improve on standard chemotherapy regimens.
The AML trials group has a history of defining standard of care treatment via the national trials, which have been adopted by the NHS, and have delivered benefit to healthcare systems on that basis.
All critical data in relation to AML15 has been published - therefore, these data will not be provided to any further public fora or pharmaceutical collaborators, unless a late safety signal emerges. The follow-on trials, which were informed by the methodology and findings from AML15, have now been designed and are underway. These trials involve different study cohorts and testing of different drugs. Therefore, the data received from NHS Digital covered by this Agreement will not be used to update future trial designs.
All outputs were aggregated with small numbers suppressed in line with the HES Analysis Guide.
Benefits reported
Results from the AML15 trial were used to further refine treatments in this population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with same condition but different patients), has been based on emerging results from the AML15 trial. Patients with APL (a sub-set of AML) have benefited significantly from the emergence of a chemotherapy-free regimen. Further advances have been made in refining the identification of patients suitable (or not) for stem cell transplant.
DARS-NIC-184980-J5B6C-v5.5 1 December 2019 to 29 February 2020
- Title
- MR826 - AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15
- Commercial
- No
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: MRIS - Cause of Death Report; MRIS - Cohort Event Notification Report; MRIS - Flagging Current Status Report; MRIS - Members and Postings Report
Objective for processing
Mortality and Cancer data were supplied to Cardiff University by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15'
This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.
Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required.
The following information provides background information on the purpose of the original study:
The Medical Research Council (MRC) has for many years run clinical trials in relation to treatment for Leukaemia. The aim of the trials is to find out whether one treatment is better than another. Usually the trials compare one treatment against another and involve most of the hospitals in the United Kingdom. Over the years this approach has led to a steady improvement in treatment.
Following the award of a research grant from the MRC, Cardiff University has led the Acute Myeloid Leukaemia (AML) 15 Trial. This trial took place in over 200 hospitals in the UK and its aim was to compare different treatments at different stages of the treatment of AML.
This work is research in the public interest as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices.
Cardiff University has determined that there are no moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data processed by Cardiff University has been pseudonymised and complies with the ICO's "Anonymisation: managing data protection risk" code of practice.
If the study participant had a common subtype of AML, the study compared different treatments which had been used in hundreds of patients before and were known to be effective but they had never been compared against each other. If information was available from diagnostic tests that a participant's leukaemia was regarded as at high risk of not responding well to the chemotherapy, he/she was eligible for randomisation to receive with the chemotherapy an additional treatment (Mylotarg) with an antibody. The study assessed whether the response in patients could be improved.
After the participant had completed the first two courses the study expected their marrow to have returned to normal. The study then went on to compare different treatments to prevent relapse.
Once the participant had completed four courses of chemotherapy, they may have been asked to enter the last question in the trial. The study aimed to find out whether adding a fifth course of treatment was beneficial. To answer this point, they were asked to agree to a fifth course of chemotherapy.
With the participant's permission, the study stored some excess cells from the blood or bone marrow for use in future research. Participants received separate information about this additional treatment and were asked to consent.
The AML-15 trial was designed for patients between 0 and 60 years with Acute Myeloid Leukaemia.
Treatment choice and outcome were substantially decided by age. The trial found that patients under 60 years have a significantly higher chance of survival with this treatment. Of patients over 60 years, who were treated intensively over the previous 15 years, there was little evidence of improvements in survival, with Complete Response (CR) rates not improved beyond 60% and relapse in 85% of patients. Large groups of patients over 60 years are not considered fit for intensive treatment - median survival is 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients over 60 years who are not catered for in most trials. Haematology Clinical Trials Unit (HCTU) based at Cardiff University used the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.
The AML15 trial was approved by the regulatory authority and research ethics committees across the UK and beyond between 2005 and 2008. Funding for the trial design was provided by Cancer Research UK and the trial was supported by the NIHR Acute Myeloid Leukaemia Working Group. The trial was formally closed to new patients in 2009 and end of trial was reported to regulatory authorities in 2012.
A total of 2,754 participants are currently involved in this study ranging from ages 0 - 60 years at the time of recruitment for participants under the age of 16 at the time of recruitment their parents/guardians consented on their behalf.
At this stage, the only requirement for accessing ongoing survival data from NHS Digital is to comply with ongoing regulatory requirements from both REC & MHRA for oversight of trial participants.
As the study sponsor, Cardiff University is the sole data controller and processor for the data received from NHS Digital.
The University of Birmingham's Birmingham Clinical Trials Unit (BCTU) was previously involved as manager of the main trial database. University of Cardiff had confirmed Birmingham Clinical Trials Unit (BCTU) no longer had access to any of the data and consequently it was removed from a previous iteration of this agreement as a named data processor. Cardiff University have since confirmed that BCTU still retain a copy of the dataset.
Expected output
No new outputs will be produced under this Data Sharing Agreement.
In any future application, the applicant will be required to provide details of any future outputs planned.
The data from the AML trials was used for two main purposes:
1. to contribute to the design of further trials and
2. to potentially update and improve on standard chemotherapy regimens.
The AML trials group has a history of defining standard of care treatment via the national trials, which have been adopted by the NHS, and have delivered benefit to healthcare systems on that basis.
All critical data in relation to AML15 has been published - therefore, these data will not be provided to any further public fora or pharmaceutical collaborators, unless a late safety signal emerges. The follow-on trials, which were informed by the methodology and findings from AML15, have now been designed and are underway. These trials involve different study cohorts and testing of different drugs. Therefore, the data received from NHS Digital covered by this Agreement will not be used to update future trial designs.
All outputs were aggregated with small numbers suppressed in line with the HES Analysis Guide.
Benefits reported
Results from the AML15 trial were used to further refine treatments in this population. The design of the subsequent AML17 and AML19 trials, in the same population of patients (i.e. patients within the same age range and with same condition but different patients), has been based on emerging results from the AML15 trial. Patients with APL (a sub-set of AML) have benefited significantly from the emergence of a chemotherapy-free regimen. Further advances have been made in refining the identification of patients suitable (or not) for stem cell transplant.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.
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July 2021 —
already listed in the earliest edition this site holds, so it may be older. 3 versions: DARS-NIC-184980-J5B6C-v5.5, DARS-NIC-184980-J5B6C-v6.4, DARS-NIC-184980-J5B6C-v7.3
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January 2022
1 version added: DARS-NIC-184980-J5B6C-v8.3
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September 2024
1 version added: DARS-NIC-184980-J5B6C-v9.5
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-184980-J5B6C, “AML15 - MRC working parties on leukaemia in adults & children acute myeloid leukaemia trial 15”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-184980-j5b6c/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-184980-J5B6C to see the original rows.