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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: Completed Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT02916979 is a Phase 1 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
100-Day survival of patients
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 |
What the finished NCT02916979 record still lists
NCT02916979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT02916979 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02916979's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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