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NCT04337515 · ClinicalTrials.gov registry record · NA
A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
A NA study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Christopher Dvorak.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT04337515: Recruiting NA study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Christopher Dvorak.
NCT04337515 is a NA study of Graft-Versus-Host Disease and Graft Vs Host Disease that is actively recruiting participants, run by Christopher Dvorak. The registered enrollment target is 90 participants, above the 80-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04337515, a NA study of Graft-Versus-Host Disease and Graft Vs Host Disease, is actively recruiting participants, sponsored by Christopher Dvorak.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
Primary Outcome
The cumulative incidence of Grade III-IV acute GVHD at Day 100 will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.37 Patients with graft rejection will be censored.
Conditions Studied
Interventions
- DEVICE CliniMacs®
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2035-01-01 |
| Phase | NA |
What NCT04337515 shows while recruiting
NCT04337515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 80-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 1 intervention - of which CliniMacs® is the first listed.
NCT04337515 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04337515 about?
NCT04337515 is a clinical study titled "A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant". Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the Clini...
What is the current status of trial NCT04337515?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2019-12-19. Estimated completion is 2035-01-01.
What conditions does trial NCT04337515 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Graft Vs Host Disease.
What interventions are being tested in trial NCT04337515?
The interventions under investigation include: CliniMacs® (DEVICE).
Who is sponsoring clinical trial NCT04337515?
This trial is sponsored by Christopher Dvorak, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04337515 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04337515's enrollment target sits among peer trials
90 6th of 38 higher than 32 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease 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.
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