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A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)
NCT00531232 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2007-05-07 |
| Est. Completion | 2011-05-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00531232
The ClinicalTrials.gov registry entry for NCT00531232 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 38 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 Myelodysplastic Syndromes 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: NCT00531232 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Illinois, New York. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00531232?
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 NCT00531232?
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 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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