- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925873
GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
June 19, 2009 updated by: French Innovative Leukemia Organisation
A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
303
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tours, France, 37000
- GOELAMS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Control arm without fludarabine
|
Other Names:
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Experimental: 2
Fludarabine arm The same regimen with fludarabine 20 mg/m2/day IV for 30 minutes
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The same regimen with addition of fludarabine in every treatment sequence
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event-free survival (EFS)
Time Frame: long term results (median follow up: 71 months)
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long term results (median follow up: 71 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS),
Time Frame: long term results (median follow up: 71 months)
|
long term results (median follow up: 71 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francis WITZ, MD, French Innovative Leukemia Organisation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1996
Primary Completion (Actual)
April 1, 2000
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
June 19, 2009
First Posted (Estimate)
June 22, 2009
Study Record Updates
Last Update Posted (Estimate)
June 22, 2009
Last Update Submitted That Met QC Criteria
June 19, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Fludarabine
- Fludarabine phosphate
- Vidarabine
Other Study ID Numbers
- GOELAMS SA4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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