Status:
COMPLETED
GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Schering SA
Novartis
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
PHASE3
Brief Summary
In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction cou...
Detailed Description
Eligibility for enrollment in the study was limited to patients aged 60 to 75 years old with previously untreated de novo AML as defined morphologically by the French-American-British (FAB) classifica...
Eligibility Criteria
Inclusion
- patients aged 60 to 75 years old
- untreated de novo AML
- performance status less than 2
Exclusion
- performance status more than 2
- congestive heart failure or abnormal left ventricular ejection fraction
- severe hepatic or renal disturbances
- history of documented myelodysplastic or myeloproliferative syndrome
- patients previously treated with chemotherapy or radiation
Key Trial Info
Start Date :
June 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00925873
Start Date
June 1 1996
End Date
November 1 2004
Last Update
June 22 2009
Active Locations (1)
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1
GOELAMS
Tours, France, 37000