Phase 2 Abatacept Dosing for Graft Versus Host Disease Prophylaxis
This study is testing two different dosing schedules of abatacept to prevent Graft Versus Host Disease (GVHD) in people receiving a stem cell transplant. GVHD is a serious complication where the donor's immune cells attack the patient's body. You might be able to join if you are at least 2 years old, weigh 10 kg, and are receiving a transplant from a specific type of unrelated donor. All participants will receive abatacept for the first four doses. Then, you will be randomly assigned to either continue with four more doses of abatacept or receive a placebo (an inactive substance) for those four doses. The main goal is to see if one dosing schedule is better at preventing severe GVHD and relapse (the return of the original disease) for at least two years after transplant. The study aims to enroll 160 participants.
- Study design
- This is a Phase 2, multicenter, randomized, double-blind study. It plans to enroll 160 participants.
- What's involved
- All patients will receive 4 doses of abatacept. Then, you will be randomly assigned to receive either 4 more doses of abatacept or 4 doses of placebo.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least one year post-transplant, with the primary outcome measured at two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
At a glance
Conditions
NCT04380740
Where you'd take part
This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgiastudy coordinator listed
Recruiting
University of Rochester
Rochester, New Yorkstudy coordinator listed
Recruiting
University of Chicago
Chicago, Illinoisno site contact published
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Active, not recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniano site contact published
Withdrawn
Cincinnati Children's Hospital
Cincinnati, Ohiono site contact published
Active, not recruiting
City Of Hope National Medical Center
Duarte, Californiano site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS)2 years
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.