Actively Recruiting
ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis
Led by Leland Metheny · Updated on 2025-06-04
20
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.
CONDITIONS
Official Title
ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with one of the following blood cancers: acute myelogenous leukemia (high or intermediate risk), acute lymphoblastic leukemia (high risk), myelodysplastic syndromes (intermediate, high, or very high risk), biphenotypic or mixed-phenotypic acute leukemia, chronic myelogenous leukemia in second chronic phase, chronic myelomonocytic leukemia, or relapsed/refractory Hodgkin lymphoma
- Age 18 to 70 years
- Karnofsky Performance Status (KPS) of at least 80 for Flu/Cy/Thio/TBI conditioning or at least 60 for Flu/Treo/TBI conditioning
- No suitable HLA-matched related or unrelated donor available
- Have at least two cord blood units with 4-8/8 HLA high resolution match, each with minimum cell doses of 1.5x10^7 total nucleated cells/kg and 1.5x10^5 CD34+ cells/kg
- Ability to understand and sign informed consent
- Women of childbearing potential must agree to remain abstinent or use highly effective contraception during treatment and for 12 months after last abatacept dose
- Men must agree to remain abstinent or use effective contraception with partners of reproductive potential during treatment and for 12 months after last abatacept dose
- Concurrent therapy for extramedullary leukemia or CNS lymphoma allowed if clinically indicated and CNS remission achieved at enrollment
You will not qualify if you...
- Kidney function with creatinine clearance less than 50 ml/min
- Liver function with bilirubin greater than twice the upper limit of normal (unless Gilbert syndrome), or AST/ALT greater than three times upper limit of normal
- Lung function with DLCOc less than 60% of normal
- Heart function with left ventricular ejection fraction less than 50%
- Uncontrolled active infection or serious heart conditions such as congestive heart failure, unstable angina, or arrhythmia
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women
- Known allergy or intolerance to study medications or their components
- Presence of donor-specific antibodies against chosen graft source
- Hematopoietic Cell Transplantation Comorbidity Index score greater than 5
- Prior stem cell transplant within 12 months
- Any condition that interferes with study participation or data interpretation as judged by the investigator
AI-Screening
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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
CONTACT
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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