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.
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
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
Single group
Cyclophosphamide
DrugCyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6.
Fludarabine
DrugFludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)
Thiotepa
DrugThiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)
Total Body Irradiation
Radiation400 cGy (200 cGy per day on days -2 and -1).
Double Umbilical Cord Transplant
Biological/VaccineCord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines.
Tacrolimus
DrugTacrolimus will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. Tacrolimus will continue at least until day 180 and then be tapered off.
Mycophenolate Mofetil
DrugMMF will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. MMF will continue until day 30.
Abatacept
DrugAbatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28.
Severe aGVHD free survival
To assess severe aGVHD (grade III-IV acute GVHD) free survival (SGFS) at T+180.
Non-relapse mortality
Treatment Related Mortality (TRM) at 1 year is the percentage of patients who expire from treatment related toxicity attributed to transplant up to 1 year after transplant.
Overall Survival
Overall Survival (OS) at 1 year is the percentage of patients alive at 1 year after transplant.
Rate of relapse
Relapse incidence at 1 year is the percentage of patients who experience relapse of their hematologic malignancy up to 1 year after transplant.
Disease free survival
Disease Free Survival at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant.
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Leland Metheny
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
