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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180167

Enrollment

492

Registered

2005-09-16

Start date

2005-01-31

Completion date

2010-07-31

Last updated

2010-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Nonlymphocytic, Acute

Keywords

Chemotherapy, elderly

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.

Interventions

DRUGrandomization between two established Chemotherapies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Complete remission rate	—
Survival	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026