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

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ClinicalTrials.gov Identifier: NCT00180167
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 20, 2010
Sponsor:
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?


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

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 ClinicalTrials.gov identifier (NCT number): NCT00180167


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

Publications:
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ClinicalTrials.gov Identifier: NCT00180167     History of Changes
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:
Chemotherapy
elderly
Additional relevant MeSH terms:
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Daunorubicin
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Mitoxantrone
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs