Status:
COMPLETED
Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC
Lead Sponsor:
Technische Universität Dresden
Conditions:
Leukemia, Nonlymphocytic, Acute
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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 proto...
Detailed Description
Randomized comparison of the two protocols.
Eligibility Criteria
Inclusion
- Diagnosis of AML
- age \>60
- no previous Chemo for AML
- informed consent
- Karnofsky \>70
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00180167
Start Date
January 1 2005
End Date
July 1 2010
Last Update
August 20 2010
Active Locations (1)
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1
Universitätsklinikum
Dresden, Saxony, Germany, D-1307