drugset / Trial / NCT00925873
GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
Phase 3
Completed
303 enrolled
French Innovative Leukemia Organisation
Novartis · collabSchering SA · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 1996-06
- Primary completion
- 2000-04
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludarabine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Active comparator (no fludarabine) | Unknown | 350 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Lomustine | Small molecule | 40 mg | Oral |
| Comparator | Molgramostim | Protein / enzyme biologic | 5 mg/kg | — |
| Comparator | Thioguanine | Small molecule | 100 mg/m2 | Oral |