Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC
Phase 4
Completed
- Conditions
- Leukemia, Nonlymphocytic, Acute
- Interventions
- Drug: randomization between two established Chemotherapies
- Registration Number
- NCT00180167
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).
- Detailed Description
Randomized comparison of the two protocols.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
Inclusion Criteria
- Diagnosis of AML
- age >60
- no previous Chemo for AML
- informed consent
- Karnofsky >70
Exclusion Criteria
- AML M3
- uncontrolled Sepsis
- uncontrolled HYpertension
- respiratory failure
- heart-failure NYHA IV, recent myocardial infarction
- severe organ dysfunction of liver, kidneys,
- HIV -infection or active Hepatitis B,C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daunorubicin + Ara-C randomization between two established Chemotherapies - Mitoxantrone + Ara-C randomization between two established Chemotherapies -
- Primary Outcome Measures
Name Time Method Complete remission rate Survival
- Secondary Outcome Measures
Name Time Method toxicity Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?
Trial Locations
- Locations (1)
Universitätsklinikum
🇩🇪Dresden, Sachsen, Germany