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

Information source: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Active comparator (no fludarabine) (Drug); Experimental (fludarabine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Official(s) and/or principal investigator(s):
Francis WITZ, MD, Principal Investigator, Affiliation: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

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.

Clinical Details

Official title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free survival (EFS)

Secondary outcome: evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS),

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

Minimum age: 60 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

GOELAMS, Tours 37000, France
Additional Information

Goelams internet site

Starting date: June 1996
Last updated: June 19, 2009

Page last updated: August 23, 2015

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