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NCT00422032 · ClinicalTrials.gov registry record · Phase 2
2 Arm Study of Clofarabine IV in MDS Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00422032: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00422032 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422032, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared. Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS. Secondary Objective: Compare response durations, survivals and side effects of the two schedules.
Primary Outcome
Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils \>/= 1 \* 10\^9/L and platelet counts \>/= 100 \* 10\^9/L, and marrow blasts \</=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to \>/= 100 \* 10\^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).
Interventions
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00422032 record still lists
NCT00422032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Clofarabine is the first listed.
NCT00422032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422032 about?
NCT00422032 is a clinical study titled "2 Arm Study of Clofarabine IV in MDS Patients". The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared. Primary Objective: Compare the respo...
What is the current status of trial NCT00422032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-01. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00422032?
The interventions under investigation include: Clofarabine (DRUG).
Who is sponsoring clinical trial NCT00422032?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00422032's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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