Leukaemia Cancer Acute myeloid leukaemia
Conditions
Interventions
Four randomised comparisons:
1. S-DAT versus H-DAT
2. All-trans retinoic acid (ATRA) versus control
3. 4 versus 5 courses of therapy in total
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukaemia (AML) (any type of de novo or secondary AML, including acute promyelocytic leukemia [APL]) 2. Suitable for intensive therapy 3. Normally under the age of 60 years (but older patients can be entered if considered suitable) 4. Informed consent given
Exclusion criteria
Exclusion criteria: 1. Previous cytotoxic therapy for leukaemia 2. Concurrent active malignancy 3. Blast transformation of CML 4. Pregnant or lactating 5. Intensive chemotherapy not considered to be an appropriate treatment option 6. Patients with APL are not eligible for the ATRA randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival; complete remission (CR) rates and reason for failure; duration of remission; toxicity; quality of life; supportive care requirements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed