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

Technische Universität Dresden492 enrolled

Overview

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).

Randomized comparison of the two protocols.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

492

Conditions

Leukemia, Nonlymphocytic, Acute

Interventions

randomization between two established ChemotherapiesDRUG

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Complete remission rate

Survival

Secondary Outcomes

toxicity

Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?

Data from ClinicalTrials.gov

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