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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380740
The ClinicalTrials.gov registry entry for NCT04380740 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 134-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (19% higher). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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