Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (NCT04380740)
A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: "ABA3"
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City Of Hope National Medical Center — Duarte, California
Age range: 2 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- City Of Hope National Medical Center — Duarte, California
- Moffitt Cancer Center — Tampa, Florida
- Emory University/Winship Cancer Center — Atlanta, Georgia
- Children's Healthcare of Atlanta — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Washington University St. Louis — St Louis, Missouri
- University of Rochester — Rochester, New York
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Oregon Health and Sciences University — Portland, Oregon
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (617) 919-2197
Email: brandi.bratrude@childrens.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Graft Vs Host Disease
- Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD — New York, New York
- A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease — Toronto, Ontario
- Horizons Chronic Graft-Versus-Host-Disease Study — Miami, Florida
- Pediatric cGVHD Symptom Scale — Phoenix, Arizona
- Chronic GVHD Response Measures Validation — Seattle, Washington
- A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant — San Francisco, California
Explore by condition: All Graft Vs Host Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.