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Completed

NCT Number: NCT00180167

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

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).

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Key information

Conditions

Leukemia, Nonlymphocytic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitätsklinikum

Dresden, Saxony, D-1307, Germany

About this study

Randomized comparison of the two protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

randomization between two established Chemotherapies

Drug

Primary outcomes

  1. Complete remission rate

  2. Survival

Secondary outcomes

  1. toxicity

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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Aug 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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