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NCT02131597 · ClinicalTrials.gov registry record · Phase 2
Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT02131597: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02131597 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02131597, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Complete Response is Normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= 1.0 x 10\^9/L, and a platelet count \>/= 100 x 10\^9/L. Hemoglobin \>/= 11 g/dL at any point while on treatment after the first cycle of therapy.
Interventions
- DRUG Guadecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-11-10 |
| Est. Completion | 2024-07-25 |
| Phase | Phase 2 |
What the finished NCT02131597 record still lists
NCT02131597 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Guadecitabine is the first listed.
NCT02131597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02131597 about?
NCT02131597 is a clinical study titled "Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes". This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT02131597?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2014-11-10. Estimated completion is 2024-07-25.
What interventions are being tested in trial NCT02131597?
The interventions under investigation include: Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT02131597?
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 NCT02131597's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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