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

This study has been completed.
Information provided by:
Technische Universität Dresden Identifier:
First received: September 13, 2005
Last updated: August 19, 2010
Last verified: August 2010

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).

Condition Intervention Phase
Leukemia, Nonlymphocytic, Acute
Drug: randomization between two established Chemotherapies
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Complete remission rate
  • Survival

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

Enrollment: 492
Study Start Date: January 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Daunorubicin + Ara-C Drug: randomization between two established Chemotherapies
Experimental: Mitoxantrone + Ara-C Drug: randomization between two established Chemotherapies

Detailed Description:

Randomized comparison of the two protocols.


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00180167

Dresden, Sachsen, Germany, D-1307
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Ulrich S. Schuler, PD Dr. med. University Hospital Dresden, Germany
  More Information

Publications: Identifier: NCT00180167     History of Changes
Other Study ID Numbers: AML_GT60_DD
Study First Received: September 13, 2005
Last Updated: August 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents processed this record on April 17, 2014