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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Active comparator (no fludarabine); Drug: Experimental (fludarabine)

• Registration Number: NCT00925873
• Lead Sponsor: French Innovative Leukemia Organisation

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 courses during maintenance.

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) classification with the exception of M3 and M7 subtypes.10,11 The bone marrow aspirate had to show at least 30 percent of nonerythroid blast cells. Patients were not eligible if they had a performance status before diagnosis of 2 or more according to the World Health Organization (WHO) grading system, congestive heart failure or abnormal left ventricular ejection fraction, severe hepatic or renal disturbances if not related to leukemia (hepatic enzymes levels over four times the normal values, serum bilirubin over 35 micromol/L, creatinine over 150 micromol/L). Patients with previous unexplained cytopenia were eligible for the study. Conversely, patients with a history of documented myelodysplastic or myeloproliferative syndrome or previously treated with chemotherapy or radiation could not enter the study. The study received in June 1996 approval from the ethics' board of the Nancy Hospital and written informed consent was given by all eligible patients before entering the study, in accordance with the Declaration of Helsinki. The enrollment period was open from November 1996 to April 2000.

Study Timeline

• Study Start: 1996-06
• Primary Completion: 2000-04
• Study Completion: 2004-11
• Study First Submitted: 2009-03-31
• Status Verified: 2009-06
• Study First Submitted QC: 2009-06-19
• Last Update Submitted: 2009-06-19
• Study First Posted: 2009-06-22
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Active comparator (no fludarabine)	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.
2	Experimental (fludarabine)	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.

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	long term results (median follow up: 71 months)

Secondary Outcome Measures

Name	Time	Method
evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS),	long term results (median follow up: 71 months)

Trial Locations

Locations (1)

GOELAMS; 🇫🇷 Tours, France