Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC
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).
Leukemia, Nonlymphocytic, Acute
Drug: randomization between two established Chemotherapies
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC|
- Complete remission rate
- Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?
|Study Start Date:||January 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Daunorubicin + Ara-C||Drug: randomization between two established Chemotherapies|
|Experimental: Mitoxantrone + Ara-C||Drug: randomization between two established Chemotherapies|
Randomized comparison of the two protocols.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180167
|Dresden, Sachsen, Germany, D-1307|
|Principal Investigator:||Ulrich S. Schuler, PD Dr. med.||University Hospital Dresden, Germany|