About this trial
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.
Eligibility criteria
Qualifiers
Antecedent hematological disease (e.g., myelodysplasia (MDS))
Treatment-related leukemia
Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)
CR2 or CR3
Disqualifiers
Creatinine clearance < 50ml/min
Bilirubin > 2X institutional upper limit of normal unless Gilbert syndrome
AST (SGOT) > 3X institutional upper limit of normal
ALT (SGPT) > 3X institutional upper limit of normal
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Fludarabine
- Thiotepa
- Total Body Irradiation
- Double Umbilical Cord Transplant
- Tacrolimus
- Mycophenolate Mofetil
- Abatacept
Treatment groups
Sponsors and collaborators
Leland Metheny
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution