Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

Technische Universität Dresden

Status and phase: Completed; Phase 4

Conditions: Leukemia, Nonlymphocytic, Acute

Treatments: Drug: randomization between two established Chemotherapies

Study type: Interventional

Funder types: Other

Identifiers

NCT00180167

AML_GT60_DD

Details and patient eligibility

About

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).

Full description

Randomized comparison of the two protocols.

Enrollment: 492 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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492 participants in 2 patient groups

Daunorubicin + Ara-C

Active Comparator group

Treatment:

Drug: randomization between two established Chemotherapies

Mitoxantrone + Ara-C

Experimental group

Treatment:

Drug: randomization between two established Chemotherapies