Clinical trial NCT00925873: GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
Official title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Fludarabine
AML
elderly patients
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Schering SA
name: Novartis
First posted: 2009-06-22
Enrollment: 303
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: long term results (median follow up: 71 months)
Secondary outcomes:
measure: evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS),
timeFrame: long term results (median follow up: 71 months)
Other outcomes:
Locations:
city: Tours
country: France
facility: GOELAMS
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Francis WITZ, MD
role: PRINCIPAL_INVESTIGATOR
References: