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NCT02916979 · ClinicalTrials.gov registry record · Phase 1
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02916979 is a Phase 1 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT02916979, a Phase 1 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study is examining a chemotherapy regimen and immune suppressive medications in the setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation \[VISTA\], cytotoxic T-lymphocyte- associated protein 4 \[CTLA-4\], programmed death-ligand 1 \[PD-L1\]) during early immune recovery following an allogeneic stem cell transplant. The site will use a myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define clinical endpoints, including engraftment, 100 day survival and one year survival (Objective #1). The site will characterize the incidence, prevalence and function of MDSCs and immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). The site will correlate these laboratory results with clinical outcomes and the incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Methotrexate
- BIOLOGICAL Rabbit ATG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-09-06 |
| Est. Completion | 2022-02-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02916979
The ClinicalTrials.gov registry entry for NCT02916979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT02916979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02916979 about?
NCT02916979 is a clinical study titled "Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG". This study is examining a chemotherapy regimen and immune suppressive medications in the setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune checkpoint regulators (V-domain...
What is the current status of trial NCT02916979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-09-06. Estimated completion is 2022-02-11.
What interventions are being tested in trial NCT02916979?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Methotrexate (DRUG), Rabbit ATG (BIOLOGICAL).
Who is sponsoring clinical trial NCT02916979?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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