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NCT04380740 · ClinicalTrials.gov registry record · Phase 2
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
A Phase 2 study of Graft Vs Host Disease, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 14
- Study locations
NCT04380740: Recruiting Phase 2 study of Graft Vs Host Disease, sponsored by Boston Children's Hospital.
NCT04380740 is a Phase 2 study of Graft Vs Host Disease that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 160 participants, above the 134-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (19% higher). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380740, a Phase 2 study of Graft Vs Host Disease, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.
Primary Outcome
SGRFS will be modeled as a time-to-event outcome, and as such, failures that occur beyond one year and before study end will be considered in the analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Abatacept
Study Locations (14)
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
California
- City Of Hope National Medical Center - Duarte
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University/Winship Cancer Center - Atlanta
Illinois
- University of Chicago - Chicago
Michigan
- University of Michigan - Ann Arbor
Missouri
- Washington University St. Louis - St Louis
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT04380740 shows while recruiting
NCT04380740 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04380740 lists 14 locations in 11 states (Massachusetts, California, Florida).
Frequently Asked Questions
What is clinical trial NCT04380740 about?
NCT04380740 is a clinical study titled "Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis". This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis,...
What is the current status of trial NCT04380740?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2022-03-30. Estimated completion is 2028-06.
What conditions does trial NCT04380740 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
What interventions are being tested in trial NCT04380740?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT04380740?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04380740 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Graft Vs Host Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04380740's enrollment target sits among peer trials
160 9th of 36 higher than 28 of 36 other Graft Vs Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft Vs 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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