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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 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02512497
The ClinicalTrials.gov registry entry for NCT02512497 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT02512497 reports 0 study locations.
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.
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