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COMPLETED Phase 2

A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

NCT00373529 · View on ClinicalTrials.gov ↗

Study Summary

Clolar (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 lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.

Interventions

  • DRUG clofarabine

Study Locations (20)

Arizona

  • Mayo Clinical Hospital — Phoenix
  • Arizona Cancer Center — Tucson

California

  • USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles
  • Scripps Cancer Center — San Diego

Georgia

  • Emory University School of Medicine — Atlanta
  • Medical College of Georgia — Augusta

Texas

  • University of MD Anderson Cancer Center — Houston
  • Cancer Care Centers of South Texas — San Antonio

Colorado

  • Rocky Mountain Cancer Centers — Denver

Connecticut

  • Cancer Center of Central Connecticut — Southington

Illinois

  • Rush University Medical Center — Chicago

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2006-10
Est. Completion 2010-05
Phase Phase 2

Sponsor

Genzyme, a Sanofi Company

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00373529

The ClinicalTrials.gov registry entry for NCT00373529 describes a study currently listed as completed. It is categorized as Phase 2, 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 116 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 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention — of which clofarabine 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: NCT00373529 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Arizona, California, Georgia. 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 NCT00373529 about?

NCT00373529 is a clinical study titled "A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)". Clolar (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 lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in e...

What is the current status of trial NCT00373529?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2006-10. Estimated completion is 2010-05.

What conditions does trial NCT00373529 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, 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 NCT00373529?

The interventions under investigation include: clofarabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00373529?

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 NCT00373529 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial