Actively Recruiting
ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis
Led by Leland Metheny · Updated on 2025-06-04
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether adding abatacept to the standard graft versus host disease (GVHD) prevention treatment of tacrolimus and mycophenolate mofetil (MMF) can reduce or prevent acute graft versus host disease (aGVHD) in people with blood cancers receiving double umbilical cord blood transplants (dCBT). This condition often affects patients after transplant and is more common in those with mismatched donors, particularly among Black, Asian, and Hispanic populations. The study is a Phase 2 trial focused on safety and effectiveness of abatacept in this setting. Participants will receive a conditioning regimen before the transplant that includes cyclophosphamide, fludarabine, thiotepa, and total body irradiation. They will then undergo a double umbilical cord blood transplant. For GVHD prevention, they will receive tacrolimus and MMF starting five days before transplant, with tacrolimus continuing for at least 180 days and MMF for 30 days. Abatacept will be administered at a dose of 10 mg/kg on days before and after transplant (day -1, and days +5, +14, and +28). Throughout the study, participants will undergo exams, tests, and procedures as part of their usual cancer care and transplant monitoring. Researchers will evaluate the rate of severe aGVHD-free survival at 180 days post-treatment as the main outcome. Additional assessments include survival rates, relapse rates, chronic GVHD incidence up to three years, infection reactivations, blood cell engraftment times, donor cell persistence, and biomarker levels related to aGVHD. The total involvement includes transplant, treatment, and follow-up assessments for up to multiple years to monitor safety and effectiveness.
CONDITIONS
Brief Title
ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with certain hematologic malignancies including high-risk or intermediate-risk acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, chronic myelogenous leukemia, chronic myelomonocytic leukemia, and relapsed or refractory Hodgkin's lymphoma
- Age between 18 and 70 years
- Karnofsky Performance Status (KPS) ≥80 for Flu/Cy/Thio/TBI regimen or KPS ≥60 for Flu/Treo/TBI regimen
- No suitable human leukocyte antigen (HLA)-matched related or unrelated donor available
- Availability of at least two 4-8/8 HLA high resolution matched cord blood units with specified cell doses and a backup cord blood unit
- Ability to understand and willingness to sign informed consent
- For women of childbearing potential: agreement to use effective contraception or abstain during treatment and for 12 months after last abatacept dose
- For men: agreement to use contraception or abstain during treatment and for 12 months after last abatacept dose
You will not qualify if you...
- Inadequate organ function including creatinine clearance < 50 ml/min, elevated bilirubin, AST, ALT, reduced pulmonary function (DLCOc < 60%), or cardiac ejection fraction < 50
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
- Pregnant or breastfeeding women
- Conditions interfering with study participation or increasing risk as judged by the investigator
- Known allergies or intolerance to study drugs or similar compounds
- Presence of donor-specific antibodies against graft source
- Hematopoietic Cell Transplantation Comorbidity Index > 5
- Prior stem cell transplant within 12 months before enrollment
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 - 6 days (Days -6 to -1)
Participants receive a conditioning regimen with cyclophosphamide, fludarabine, thiotepa, and total body irradiation to prepare for transplant.
Daily visits during conditioning
Duration - Up to 180 days post transplant
Participants undergo double umbilical cord blood transplant and receive abatacept, tacrolimus, and mycophenolate mofetil for graft-versus-host disease prophylaxis.
1 transplant day and multiple visits on Days -1, 5, 14, 28, and regular visits up to Day 180
Duration - Up to 3 years
Participants are monitored for outcomes including graft-versus-host disease, survival, and immune recovery up to 3 years post transplant.
Periodic visits up to 3 years post transplant
Trial Site Locations
Total: 1 location
1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Leland Metheny, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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