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NCT00317642 · ClinicalTrials.gov registry record · Phase 3
A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
A Phase 3 study of Acute Myelogenous Leukemia, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
- 20
- Study locations
NCT00317642 is a Phase 3 study of Acute Myelogenous Leukemia that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 326 participants, above the 131-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (149% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT00317642, a Phase 3 study of Acute Myelogenous Leukemia, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
- 20
- Study locations
Study Summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in older patients. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is benefit by combining clofarabine with cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either placebo in combination with cytarabine or clofarabine in combination with cytarabine. Randomization was stratified by remission status following the first induction regimen (no remission \[i.e., CR1 = refractory\] or remission \<6 months vs CR1 = remission ≥6 months). CR1 is defined as remission after first pre-study induction regimen. The safety and tolerability of clofarabine in combination with cytarabine and cytarabine alone will be monitored throughout the study.
Conditions Studied
Interventions
- DRUG placebo
- DRUG cytarabine
- DRUG clofarabine (IV formulation)
Study Locations (20)
California
- Scripps Cancer Center - La Jolla
- UCLA School of Medicine - Los Angeles
- University of Southern California, Kenneth Norris Cancer Center - Los Angeles
- Stanford Comprehensive Cancer Center - Stanford
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- Evanston Northwestern Healthcare - Evanston
Arizona
- Mayo Clinical Hospital - Scottsdale
- Arizona Cancer Center - Tucson
Colorado
- University of Colorado Health Science Center - Aurora
- Rocky Mountain Cancer Center - Denver
Arkansas
- University of Arkansas for Medical Sciences, Arkansas Cancer Research Center - Little Rock
Connecticut
- Cancer Center of Central Connecticut - Southington
Kansas
- University of Kansas Medical Center - Kansas City
Kentucky
- University of Kentucky, Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00317642
The ClinicalTrials.gov registry entry for NCT00317642 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 131-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (149% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00317642 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT00317642 about?
NCT00317642 is a clinical study titled "A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)". Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. There is no recommended standard treatment for rel...
What is the current status of trial NCT00317642?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2006-08. Estimated completion is 2012-01.
What conditions does trial NCT00317642 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00317642?
The interventions under investigation include: placebo (DRUG), cytarabine (DRUG), clofarabine (IV formulation) (DRUG).
Who is sponsoring clinical trial NCT00317642?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00317642 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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