Status:
UNKNOWN
Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
University of Ulm
Johann Wolfgang Goethe University Hospital
Conditions:
De Novo Akute Myeloid Leukemia (AML)
Secondary Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to...
Detailed Description
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype. ...
Eligibility Criteria
Inclusion
- diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
- diagnosis of secondary AML after chemo-/radiotherapy or MDS
- diagnosis of RAEB-T
- age between 16 and 60 years (including 60 years)
- women after exclusion of pregnancy
- written informed consent
Exclusion
- patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
- patients with DLCO \< 50%
- patients with creatinine clearance \< 60 ml/min
- patients with bilirubin \> 2mg% (34.2 mmol/L)
- patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
- patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
- HIV positivity
- patients with a t(15;17) translocation
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00209833
Start Date
January 1 1999
End Date
September 1 2005
Last Update
November 18 2005
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625