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| [ Print-friendly version ] |
| A trial of directed therapy in younger patients with acute myeloid leukaemia: MRC AML 15 |
| ISRCTN | ISRCTN17161961 |
| ClinicalTrials.gov identifier | |
| Public title | A trial of directed therapy in younger patients with acute myeloid leukaemia: MRC AML 15 |
| Scientific title | |
| Acronym | MRC AML 15 |
| Serial number at source | G9901427 |
| Study hypothesis |
The AML trial has two separate parts:
1. For patients with Acute Myeloid Leukaemia (AML), other than acute promyelocytic leukaemia (APL), as defined by the World Health Organisation (WHO) classification (2001). 2. For patients with Acute Promyelocytic Leukaemia (APL). The objectives for each of these components are summarised below. Therapeutic questions for patients with non-APL AML: For patients with acute myeloid leukaemia (AML) the aims of the AML15 trial are: 1. To compare two induction schedules (namely DAT and FLAG-Ida) 2. To assess the value of Mylotarg during induction 3. To compare the standard MRC consolidation chemotherapy (i.e. MACE + MidAC) versus high-dose Ara-C 4. For those allocated to high-dose Ara-C to compare high-dose ARA-C during consolidation (see above) at two different doses (1.5 g/m squared versus 3.0g/m squared) 5. To assess the value of Mylotarg during consolidation 6. To compare four versus five courses of treatment in total (where the final course is intermediate-dose Ara-C) 7. In standard and poor risk patients, to evaluate, by means of a genetic randomisation, the value of allogeneic stem cell transplantation [SCT, whether standard allogeneic (allo-SCT) or non-myeloablative ‘mini’ allogeneic (mini-SCT)] Therapeutic questions for patients with APL. For patients with APL: 1. To compare the MRC approach (i.e. four courses of intensive chemotherapy) with the Spanish approach (based on anthracyclines with maintenance therapy) 2. To assess the value of Mylotarg during consolidation (i.e. with course 3) |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Leukaemia |
| Participants - inclusion criteria |
1. Any form of de novo or secondary AML
2. Suitable for intensive chemotherapy 3. Under 60 years 4. Written consent |
| Participants - exclusion criteria |
1. Previous chemotherapy for AML
2. Blast transferration of CML 3. Pregnant or lactating 4. Abnormal liver function tests for Mylotarg randomisations |
| Anticipated start date | 01/03/2002 |
| Anticipated end date | 01/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 3000 |
| Interventions |
1. (R1) Patients with acute promyelocytic leukemia (APL) will be randomised to receive oral retinoic acid together with either MRC H-DAT chemotherapy or the Spanish Intermittent Idarubicin. Following confirmation of remission, patients will continue with the MRC (DAT:MACE:MIDAC) or Spanish chemotherapy but will be randomised to receive CMA-676/Myelotarg (Immunoconjugate) on day 1 of course 3 or not. (Patients will be monitered molecularly by Reverse Transcription (RT) and real time Polymerase Chain Reaction (PCR) to predict relapse. Three quality of life assessments will be made at 3, 6 and 9 months and resource use information will be collected for cost benefit analysis.)
2. (R2) Non-APL patients will be randomised to receive induction cources 1 and 2 with H-Dat (Daunorbicin:Ara-C, Thioguanine) or FLA_G IDA (Fludarabine, Ara C, G-CSF, Idarubicin) and to receive CMA-676 (Myelotarg) on day 1 of course 1 or not. 3. Following the first course of chemotherapy the risk profile of each patient will be determined (based on cytogenetics, blast clearance after course 1). Good risk patients (15%) will leave AML15 and will enter the MRC AML High Risk Trial. 4. (R3)(R4) Patients who have completed course 2 and are allocated to the chemotherapy comparisons will be randomised to receive CMA-676 (Myelotarg) on day 1 of course 3. 5. (R5) All patients allocated to allogenic transplant up to 35 years will receive standard conditioning (Cyclophosphamide/TBI) with stem cells obtained from peripheral blood or bone marrow as course 3. For patients 36-50 investigators may choose a conventional transplant or a non-ablative transplant. Patients over 50 years will receive a non-ablative transplant. The non-ablative transplant will be given as course 4, ie patients will receive MACE as course 3 before proceeding to transplant. 7. Patients who relapse at any point in the trial will be entered into the MRC AML HR Trial. |
| Primary outcome measure(s) |
The main endpoints for each comparison will be:
1. Complete remission (CR) achievement and reasons for failure (for induction questions) 2. Duration of remission, relapse rates and deaths in first CR 3. Overall survival 4. Toxicity, both haematological and non-haematological, and quality of life 5. Supportive care requirements (and other aspects of health economics) |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (UK) |
| Trial website | |
| Publications | Results of a feasibility study for MRC AML15 trial: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12933575 |
| Contact name | Prof AK Burnett |
| Address |
Department of Haematology
University of Wales College of Medicine Heath Park |
| City/town | Cardiff |
| Zip/Postcode | CF14 4XN |
| Country | United Kingdom |
| Tel | +44 (0)29 2074 2375 |
| Fax | +44 (0)29 2074 4655 |
| burnettak@cardiff.ac.uk | |
| Sponsor | Cardiff University (UK) |
| Address | |
| City/town | Cardiff |
| Zip/Postcode | CF10 3XQ |
| Country | United Kingdom |
| Tel | +44 (0)29 2087 4000 |
| Date applied | 02/05/2001 |
| Last edited | 18/07/2007 |
| Date ISRCTN assigned | 02/05/2001 |
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