GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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 courses during maintenance.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborators: Novartis; Schering SA
• Treatments: Fludarabine; Fludarabine phosphate; Idarubicin; Vidarabine

Criteria

Inclusion Criteria:

• patients aged 60 to 75 years old

• untreated de novo AML

• performance status less than 2

Exclusion Criteria:

• 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