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

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00180167
First received: September 13, 2005
Last updated: August 19, 2010
Last verified: August 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00180167

Locations
Germany
Universitätsklinikum
Dresden, Sachsen, Germany, D-1307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Ulrich S. Schuler, PD Dr. med. University Hospital Dresden, Germany
  More Information

Publications:

ClinicalTrials.gov 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 Dresden University of Technology:
Chemotherapy
elderly

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Cytarabine
Daunorubicin
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013