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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: Completed Phase 3 study of Acute Myelogenous Leukemia, sponsored by Genzyme, a Sanofi Company.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.

Conditions Studied

Acute Myelogenous Leukemia

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

FieldValue
Enrollment Target 326 participants
Start Date 2006-08
Est. Completion 2012-01
Phase Phase 3
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00317642 record still lists

NCT00317642 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, above the 131-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (149% higher).

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 names 20 study sites across 13 states, led by 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.

Learn More About Clinical Trials

Similar trials for Acute Myelogenous Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00317642's enrollment target sits among peer trials

326 3rd of 38 higher than 36 of 38 other Acute Myelogenous Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myelogenous Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00317642, the US trial registry maintained by the National Library of Medicine. NCT00317642 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.