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NCT01937468 · ClinicalTrials.gov registry record · Phase 1
Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
A Phase 1 study of Chronic Graft Versus Host Disease and Chronic GVHD, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT01937468 is a Phase 1 study of Chronic Graft Versus Host Disease and Chronic GVHD that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 25 participants, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01937468, a Phase 1 study of Chronic Graft Versus Host Disease and Chronic GVHD, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is a Phase I clinical trial, which tests the safety of an investigational combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg cells to use for further studies. IL-2 is involved with cell signaling and regulation of white blood cells (WBCs). WBCs are part of the immune system. Treg cells are also part of the immune system; they are involved with anti-inflammatory responses. "Investigational" means that the combination of IL-2 and anti-inflammatory Treg cell infusion is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the combination of IL-2 and anti-inflammatory Treg cell infusion for use in people with cGVHD. Chronic GVHD is a medical condition that may occur after you have received your bone marrow, stem cell or cord blood transplant from a donor. The donor's immune system may recognize your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host disease. Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this trial have not responded to steroid therapy. The investigators are looking to assess the safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells, that may help control cGVHD by stopping the donor's immune system from 'rejecting' your body.
Conditions Studied
Interventions
- DRUG Interleukin-2
- OTHER Treg-enriched infusion
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Insitute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-11 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01937468
The ClinicalTrials.gov registry entry for NCT01937468 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (78% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Interleukin-2 is the first listed.
NCT01937468 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01937468 about?
NCT01937468 is a clinical study titled "Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease". This research study is a Phase I clinical trial, which tests the safety of an investigational combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg cells to use for furthe...
What is the current status of trial NCT01937468?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-11. Estimated completion is 2026-12.
What conditions does trial NCT01937468 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease, Chronic GVHD, Complications of Organ Transplant Stem Cells.
What interventions are being tested in trial NCT01937468?
The interventions under investigation include: Interleukin-2 (DRUG), Treg-enriched infusion (OTHER).
Who is sponsoring clinical trial NCT01937468?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01937468 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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