Actively Recruiting
A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: ABA3
Led by Boston Children's Hospital · Updated on 2026-05-11
160
Participants Needed
15
Research Sites
56 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
Researchers are studying patients receiving transplants from donors who are 7 out of 8 human leukocyte antigen (HLA) matches to see if different dosing schedules of abatacept can improve outcomes. This Phase 2, multicenter, randomized, double-blind trial compares an extended dosing regimen of abatacept to a short-term dosing regimen plus placebo, both added to standard graft-versus-host disease (GVHD) prevention treatments. The main goal is to evaluate survival free from severe acute GVHD, severe chronic GVHD, and relapse over a follow-up period of at least one year post-transplant. All participants initially receive four abatacept doses on days -1, +5, +14, and +28 relative to transplant. Before the fifth dose, participants are randomly assigned to either continue with four additional abatacept doses (extended dosing group) or receive four placebo doses instead (short-term dosing group). Both groups also receive standard GVHD prophylaxis using calcineurin inhibitors (cyclosporine or tacrolimus) and methotrexate. The study continues until every participant has reached two years after their transplant. Throughout the study, researchers monitor participants for survival without severe GVHD or relapse at two years, as well as secondary outcomes like severe chronic GVHD, relapse-free survival, and non-relapse mortality. Safety is closely tracked, and the study will be unblinded after the last participant reaches one year post-transplant. Participants are involved in regular follow-ups to assess these outcomes and overall health during the trial period.
CONDITIONS
Brief Title
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 2 years old and weigh at least 10 kg.
- Must have a willing unrelated adult donor who is a 7 out of 8 HLA match.
- All patients and/or their parents or legal guardians must sign written informed consent; assent obtained when appropriate.
- Must have a hematologic malignancy treatable by hematopoietic cell transplantation that is currently in remission.
- Patients with inherited predispositions to leukemia or hematologic malignancies not linked to transplant risks are eligible.
- Karnofsky or Lansky performance score of 80 or higher.
You will not qualify if you...
- Patients with chronic lymphocytic leukemia, myeloma, or primary myelofibrosis.
- Active relapse with more than 5% blasts.
- For acute lymphocytic leukemia, pre-transplant minimal residual disease (MRD) greater than 0.01% when tested.
- For myelodysplastic syndromes, more than 5% blasts.
- Prior allogeneic hematopoietic cell transplant.
- Uncontrolled infections of viral, bacterial, fungal, or protozoal origin.
- HIV infection.
- Serious psychiatric diseases like schizophrenia, bipolar disorder, or severe depression.
- Prisoners or individuals compulsorily detained.
- Known or suspected inherited predisposition to transplant morbidities or non-hematologic cancers like Fanconi Anemia or Li-Fraumeni syndrome.
- Active non-hematologic cancers (except non-melanoma skin cancers) or those not disease-free for at least 2 years.
- Incomplete treatment of active tuberculosis.
- Pregnancy or breastfeeding.
- Kidney function estimated glomerular filtration rate below 50 mL/min/1.73 m2.
- Cardiac ejection fraction below 50%.
- Liver or unresolved veno-occlusive disease abnormalities.
- Severe lung disease requiring oxygen or with low lung function.
- Presence of antibodies against mismatched donor HLA antigens.
- Development of severe acute or chronic GVHD or relapse before randomization.
- Severe allergic reaction to abatacept during first four doses or clinical events preventing further dosing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 dosing sessions over the prophylaxis period
Participants receive standard GVHD prophylaxis including a calcineurin inhibitor and methotrexate, combined with either 4 doses of abatacept plus 4 doses of placebo, or 8 doses of abatacept during the treatment period.
Up to 8 dosing visits (in-person)
Duration - Up to 2 years
Participants are monitored for outcomes including severe acute and chronic GVHD, relapse, and survival for up to 2 years after treatment.
Periodic visits over 2 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here