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NCT02512497 · ClinicalTrials.gov registry record · Phase 1
Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02512497: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT02512497 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02512497, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole body) therapy before. Busulfan and fludarabine are FDA approved and commercially available for use with a stem cell transplant. The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of leukemia or lymphoma you have is considered investigational. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
Toxicity defined as death from any cause, grade 3 or 4 graft-versus-host disease, grade 3-4 mucositis lasting for more than 3 days at peak severity, or or grade 3 or 4 non-hematologic non-infectious toxicity within 30 days of receiving the first Romidepsin administration on day -6 (day 24 post allosct).
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Thymoglobulin
- DRUG Romidepsin
- PROCEDURE Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2025-06-18 |
| Phase | Phase 1 |
What the finished NCT02512497 record still lists
NCT02512497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT02512497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02512497 about?
NCT02512497 is a clinical study titled "Romidepsin Maintenance After Allogeneic Stem Cell Transplantation". The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this...
What is the current status of trial NCT02512497?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2017-12-08. Estimated completion is 2025-06-18.
What interventions are being tested in trial NCT02512497?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Thymoglobulin (DRUG), Romidepsin (DRUG), Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT02512497?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02512497's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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