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NCT01444742 · ClinicalTrials.gov registry record · Phase 2
Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01444742: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01444742 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01444742, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Primary Outcome
Complete Response Criteria (CR must last for at least 4 weeks): Marrow: \</= 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) \>/= 11 g/dL (untransfused, patient not on EPO); Neutrophils \>/= 1x109/L (not on myeloid growth factor); Platelets \>/= 100 \* 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor respon
Interventions
- DRUG Cytarabine
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-11-16 |
| Est. Completion | 2017-01-29 |
| Phase | Phase 2 |
What the finished NCT01444742 record still lists
NCT01444742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT01444742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01444742 about?
NCT01444742 is a clinical study titled "Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied. Clofarabine is designe...
What is the current status of trial NCT01444742?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2011-11-16. Estimated completion is 2017-01-29.
What interventions are being tested in trial NCT01444742?
The interventions under investigation include: Cytarabine (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01444742?
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 NCT01444742's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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