Actively Recruiting
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Led by Boston Children's Hospital · Updated on 2026-05-11
160
Participants Needed
15
Research Sites
322 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 2 years old and weighs at least 10 kilograms
- Has a willing unrelated adult donor matched 7 out of 8 HLA alleles
- All patients or their guardians provide written informed consent
- Has a blood cancer treatable by transplant that is in remission
- Karnofsky or Lansky performance score of 80 or higher
- Patients with inherited predisposition to leukemia or hematologic cancer without transplant risks are eligible
You will not qualify if you...
- Diagnosed with chronic lymphocytic leukemia, myeloma, or primary myelofibrosis
- Active relapse of cancer with more than 5% blasts
- For acute lymphocytic leukemia, minimal residual disease over 0.01% pre-transplant
- For myelodysplastic syndrome, more than 5% blasts
- Prior allogeneic stem cell transplant
- Uncontrolled infections at enrollment
- HIV infection
- Serious psychiatric conditions like schizophrenia or severe depression
- Prisoners or those involuntarily detained
- Known inherited predisposition to transplant complications or non-blood cancers (e.g., Fanconi anemia, Li-Fraumeni syndrome)
- Active non-blood cancers or those disease-free for less than 2 years
- Untreated active tuberculosis
- Pregnancy or breastfeeding
- Kidney function estimated below 50 mL/min/1.73m2
- Heart ejection fraction below 50%
- Liver function abnormalities or unresolved liver disease
- Severe lung disease or need for supplemental oxygen
- Presence of antibodies against donor HLA antigens
- Development of severe acute or chronic GVHD or relapse before randomization
- Severe allergic reaction to initial abatacept doses or other events preventing further dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
City Of Hope National Medical Center
Duarte, California, United States, 91010
Active, Not Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
3
Emory University/Winship Cancer Center
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Active, Not Recruiting
11
Washington University St. Louis
St Louis, Missouri, United States, 63110
Withdrawn
12
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
13
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Active, Not Recruiting
14
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Active, Not Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
Research Team
B
Brandi M Bratrude, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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