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

This study has been completed.
Schering SA
Information provided by:
French Innovative Leukemia Organisation Identifier:
First received: March 31, 2009
Last updated: June 19, 2009
Last verified: June 2009
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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Active comparator (no fludarabine) Drug: Experimental (fludarabine) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

Resource links provided by NLM:

Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: long term results (median follow up: 71 months) ]

Secondary Outcome Measures:
  • evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS), [ Time Frame: long term results (median follow up: 71 months) ]

Enrollment: 303
Study Start Date: June 1996
Study Completion Date: November 2004
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

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.
Drug: Active comparator (no fludarabine)
  1. Ara-C (100 mg/m2/d by continuous IV infusion 7 days), idarubicin (8 mg/m2/d (IV) for 5 days), GM-CSF a dose of 5 mg/kg/d on day 1. (Novartis Laboratory, Rueil-Malmaison, France).
  2. The consolidation course: intermediate-dose Ara-C (1g/m2 g 3-hour infusion twice a day 1 through 3) and idarubicin (10 mg/m2 on days 4 through 5). In the allocated arm
  3. Maintenance therapy for one year with 6-thioguanine (100 mg/m2/d orally on days 1 through 4 every week, Ara-C (60 mg/m2 SC on day 5 weekly) interrupted every 3 months with a reinduction course including CCNU (40 mg orally on day 1), mitoguazone (350 mg/m2 on day 1) and Ara-C (40 mg/m2 sc twice daily day 1 to 5)
Other Name: Arm A
Experimental: 2

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.
Drug: Experimental (fludarabine)

The same regimen with addition of fludarabine in every treatment sequence

  1. Induction course: Fludarabine (20 mg/m2/d, IV for 30 minutes) was started in the assigned group on day 2 and continued until the end of cytarabine treatment on day 7.
  2. Consolidation course: In the allocated arm, fludarabine (20 mg/m2/d, IV) was administered on days 2 through 3, 4 hours prior to cytarabine infusion.
  3. Reinduction courses: Ara-C associated in the allocated group with fludarabine (20 mg/m2/d, IV) on days 1 through 2.
Other Name: Arm B

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.

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00925873

Tours, France, 37000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Schering SA
Principal Investigator: Francis WITZ, MD French Innovative Leukemia Organisation
  More Information

Responsible Party: Dr Francis WITZ, GOELAMS Identifier: NCT00925873     History of Changes
Other Study ID Numbers: GOELAMS SA4
Study First Received: March 31, 2009
Last Updated: June 19, 2009

Keywords provided by French Innovative Leukemia Organisation:
elderly patients

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on July 24, 2017