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NCT01634217 · ClinicalTrials.gov registry record · Phase 1
Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01634217 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 16 participants.
The verdict
NCT01634217, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a phase I single center dose escalation study with an extension at the best available dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in this treatment setting.
Interventions
- BIOLOGICAL iTreg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-11-08 |
| Est. Completion | 2018-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01634217
The ClinicalTrials.gov registry entry for NCT01634217 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which iTreg is the first listed.
NCT01634217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01634217 about?
NCT01634217 is a clinical study titled "Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation". This is a phase I single center dose escalation study with an extension at the best available dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem cell (PBSC) transplant...
What is the current status of trial NCT01634217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-11-08. Estimated completion is 2018-12-01.
What interventions are being tested in trial NCT01634217?
The interventions under investigation include: iTreg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01634217?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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