ISRCTN88373119Completed未知
Acute Myeloid Leukaemia - High Risk (AML-HR)
Medical Research Council (MRC) (UK)0 sites600 target enrollmentStarted: October 25, 2000Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 600
Study Overview
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. High risk acute myeloid leukaemia (AML) (de novo or secondary, except acute promyelocytic leukemia [APL])
- •2. Suitable for intensive therapy
- •3. Informed consent given. High risk AML is defined as:
- •(a) Resistant disease (greater than 15% blasts in bone marrow) after one induction course
- •(b) Refractory disease (ie not in complete remission [CR]) after two or more induction courses
- •(c) Relapse from first CR (with more than 5% blasts in bone marrow)
- •(d) In complete or partial remission after one induction course but with adverse cytogenic abnormalities at diagnosis
Exclusion Criteria
- •2. Concurrent active malignancy
- •3. Blast transformation of CML
- •4. Relapse from second or greater CR
- •5. Severe renal impairment (creatinine clearance less than 30 millilitres per minute)
- •6. Pregnant, lactating or potentially fertile and not taking adequate contraceptive precautions
Investigators
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