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NCT00373529 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
116
Enrollment target
20
Study locations

NCT00373529 is a Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 116 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 16 states.

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The verdict

NCT00373529, a Phase 2 study of Acute Myeloid Leukemia and Acute Myelogenous Leukemia, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
116 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Acute Myeloid Leukemia Acute Myelogenous Leukemia

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

196 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, categorized as Phase 2. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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.

NCT00373529 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Arizona, California, Georgia.

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.

What interventions are being tested in trial NCT00373529?

The interventions under investigation include: clofarabine (DRUG).

Who is sponsoring clinical trial NCT00373529?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.