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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180167
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 20, 2010
Information provided by:
Technische Universität Dresden

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).

Condition or disease Intervention/treatment Phase
Leukemia, Nonlymphocytic, Acute Drug: randomization between two established Chemotherapies Phase 4

Detailed Description:
Randomized comparison of the two protocols.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Active Comparator: Daunorubicin + Ara-C Drug: randomization between two established Chemotherapies
Experimental: Mitoxantrone + Ara-C Drug: randomization between two established Chemotherapies

Primary Outcome Measures :
  1. Complete remission rate
  2. Survival

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180167

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Dresden, Sachsen, Germany, D-1307
Sponsors and Collaborators
Technische Universität Dresden
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Principal Investigator: Ulrich S. Schuler, PD Dr. med. University Hospital Dresden, Germany
Layout table for additonal information Identifier: NCT00180167    
Other Study ID Numbers: AML_GT60_DD
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010
Keywords provided by Technische Universität Dresden:
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid