AML16 Study Summary (Version 7: March 2010)
A PROGRAMME OF DEVELOPMENT FOR OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA AND HIGH RISK MYELODYSPLASTC SYNDROME. (Trial Reference ISRCTN 11036523)
The AML16 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years, but younger patients who may not be considered suitable for the concurrent MRC AML Trial for younger patients may also enter. Approximately 2000 patients will be recruited.
The Programme is in two parts. For patients who are considered fit for an intensive approach to treatment, a randomisation will compare two standard chemotherapy schedules DA (Daunorubicin/Ara-C) with ADE (Daunorubicin/Ara- C/Etoposide). In addition, the role of all-trans-retinoic Acid (ATRA) in combination with these treatments in the first induction course will be evaluated. Patients who achieve complete remission (CR) or partial remission (PR) after course one will receive a second course of the same treatment with the ATRA if allocated to do so, and will then be randomised to one further course or not and will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available. Patients who fail to achieve a CR or PR after course 1 and are in CR after course 2 will receive course 3. Patients who do not have a donor will be randomised to maintenance with Azacytidine or not.
Patients who are not considered fit for an intensive treatment approach will be randomised between an established approach to non-intensive treatment, namely Low Dose Ara-C versus one of two novel treatments, which are Low Dose Clofarabine or Sapacitabine.
There are about 2000 cases of AML each year in adults aged over 60 years in the British Isles alone. About 270 patients over 60 years annually enter national trials, which offer an intensive treatment approach. It is expected that a similar number of patients can be recruited to the non-intensive treatment options of this trial.
This protocol describes a collaborative trial in acute myeloid leukaemia primarily for patients over 60 years, which is being undertaken by the NCRI Haematological Oncology Study Group under the sponsorship of Cardiff University, and provides information about procedures for the entry, treatment and follow-up of patients. It is not intended that this protocol should be used as an aide-memoire or guide for the treatment of other patients. Every care has been taken in its drafting, but corrections or amendments may be necessary. Before entering patients into the trial, clinicians must ensure that the trial protocol has received clearance from their Local Research Ethics Committee and that they conform to the host institution’s Research Governance procedures. During the course of this 6-year trial, not all randomisation options will be open at all times and some additional options may be included by protocol amendment.
Clinicians are asked to read the whole protocol before commencing treatment