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NCT00531232 · ClinicalTrials.gov registry record · Phase 2

A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

A Phase 2 study of Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia (AML), sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
6
Study locations

NCT00531232 is a Phase 2 study of Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia (AML) that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 38 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00531232, a Phase 2 study of Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia (AML), has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
6
Study locations

Study Summary

There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.

Conditions Studied

Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia (AML)

Interventions

  • DRUG Clofarabine

Study Locations (6)

Texas

  • Baylor University Medical Center Blood Marrow Transplantation Research - Dallas
  • University of Texas MD Anderson Cancer Center - Houston

Illinois

  • The University of Chicago - Chicago

New York

  • Weill Medical College of Cornell University - New York

North Carolina

  • Wake Forest University Baptist Medical Center - Winston-Salem

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2007-05-07
Est. Completion 2011-05-12
Phase Phase 2

Sponsor

Genzyme, a Sanofi Company

196 total trials

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What the Registry Record Tells You About NCT00531232

The ClinicalTrials.gov registry entry for NCT00531232 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (87% lower). 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 Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Clofarabine is the first listed.

NCT00531232 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Texas, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT00531232 about?

NCT00531232 is a clinical study titled "A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)". There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. Aft...

What is the current status of trial NCT00531232?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2007-05-07. Estimated completion is 2011-05-12.

What conditions does trial NCT00531232 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia (AML).

What interventions are being tested in trial NCT00531232?

The interventions under investigation include: Clofarabine (DRUG).

Who is sponsoring clinical trial NCT00531232?

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

Where is trial NCT00531232 being conducted?

This trial has 6 study locations across Illinois, New York, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.