Clinical trial · Interventional
GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients
NCT00925873CI-TRIAL-00002398completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active comparator (no fludarabine) | Drug | — | UNRESOLVED |
| Experimental (fludarabine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Control arm without fludarabine 1. Induction course: Ara-C 100mg/m2 days 1-7, idarubicin 8mg/m2 days 1-5, GM-CSF (molgramostim, Novartis) 5 microg/kg days 1 to neutrophil recovery; 2. Consolidation course: Ara-C 1g/m2 q12h days 1-3, idarubicin 10mg/m2 days 2-3; 3. and 3 quarterly reinduction courses during maintenance including Ara-C 80mg/m2 days 1-5, CCNU 40mg and mitoguazone 350mg/m2 day 1, ± fludarabine days 1-2.
- interventionNames
- Drug: Active comparator (no fludarabine)
- type
- EXPERIMENTAL
- label
- 2
- description
- Fludarabine arm The same regimen with fludarabine 20 mg/m2/day IV for 30 minutes 1. induction course + fludarabine days 2-7; 2. consolidation course + fludarabine days 4-5; 3. during reinduction courses + fludarabine days 1-2.
- interventionNames
- Drug: Experimental (fludarabine)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.