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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: Completed Phase 2 study of Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia (AML), sponsored by Genzyme, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Response: complete remission(CR) or marrow CR or partial remission (PR), or hematologic improvement (HI) in participants with myelodysplastic syndromes (MDS);CR or CR with incomplete count recovery(CRi),or PR in participants with secondary acute myeloid leukemia (sAML). Per International Working Group (IWG) criteria, CR:\<= 5% myeloblasts in bone marrow; persistent dysplasia had to be noted; peripheral blood showing hemoglobin (Hgb)\>=11g/dL, platelets \>=100\*10\^9/L,neutrophils \>=1\*1
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 |
What the finished NCT00531232 record still lists
NCT00531232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (87% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT00531232's enrollment target sits among peer trials
38 103rd of 173 higher than 66 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.
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