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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

60 and over

Other

AML_GT60_DD
NCT00180167

Trial Description

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).

Further Study Information

Randomized comparison of the two protocols.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Technische Universitaet Dresden

Ulrich S. Schuler, PD Dr. med.

Principal Investigator

Ulrich S Schuler, PD Dr.med.		Ph: 49 351 458 Ext.4670
		Email: ulrich.schuler@uniklinikum-dresden.de

Gerhard Ehninger, Prof.Dr.med.		Ph: 49 351 458 Ext.4190
		Email: gerhard.ehninger@uniklinikum-dresden.de

Trial Sites

Germany

Dresden

Universitatsklinikum Carl Gustav Carus

Ulrich S Schuler, PD Dr. med. Ph: 49351 458 4670

Email: ulrich.schuler@uniklinikum-dresden.de

ulrich S Schuler, PD Dr. med. Principal Investigator

Markus Schaich, PD Dr. med. Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00180167
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.