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NCT06681922 · ClinicalTrials.gov registry record · Phase 1
A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
A Phase 1 study of Graft Vs Host Disease, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06681922: Recruiting Phase 1 study of Graft Vs Host Disease, sponsored by Northwell Health.
NCT06681922 is a Phase 1 study of Graft Vs Host Disease that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 10 participants, below the 138-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06681922, a Phase 1 study of Graft Vs Host Disease, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.
Conditions Studied
Interventions
- DRUG Cyclophosphamide, Bortezomib, Abatacept
Study Locations (1)
New York
- Zuckerberg Cancer Center - Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What NCT06681922 shows while recruiting
NCT06681922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 138-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Cyclophosphamide, Bortezomib, Abatacept is the first listed.
NCT06681922 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06681922 about?
NCT06681922 is a clinical study titled "A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)". The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design s...
What is the current status of trial NCT06681922?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-09-23. Estimated completion is 2027-10.
What conditions does trial NCT06681922 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
What interventions are being tested in trial NCT06681922?
The interventions under investigation include: Cyclophosphamide, Bortezomib, Abatacept (DRUG).
Who is sponsoring clinical trial NCT06681922?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06681922 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06681922's enrollment target sits among peer trials
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