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A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
NCT00317642 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00317642 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00317642?
The interventions under investigation include: placebo (DRUG), cytarabine (DRUG), clofarabine (IV formulation) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00317642?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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