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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


Phase 4
60 Years
N/A
Not Enrolling
Both
Leukemia, Nonlymphocytic, Acute

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Trial Information

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


Randomized comparison of the two protocols.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate

Principal Investigator

Ulrich S. Schuler, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Dresden, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AML_GT60_DD

NCT ID:

NCT00180167

Start Date:

January 2005

Completion Date:

July 2010

Related Keywords:

  • Leukemia, Nonlymphocytic, Acute
  • Chemotherapy
  • elderly
  • Leukemia
  • Leukemia, Myeloid, Acute

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