A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT)
This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or ≥7 out of 8 allele level HLA matched unrelated donor are eligible for the study if they meet the criteria defined in our standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Subjects will receive a standard of care conditioning regimen. Subjects will receive investigational PTCy, investigational bortezomib and investigational abatacept as GvHD prophylaxis.
• Age ≥14 years
• Karnofsky score ≥70%
• No evidence of progressive bacterial, viral, or fungal infection
• Creatinine clearance \>50 mL/min/1.72m2
• ALT and AST \<3 x the upper limit of normal
• Total bilirubin \<2 x the upper limit of normal (except for Gilbert's syndrome)
• Alkaline phosphatase ≤250 IU/L
• Left Ventricular Ejection Fraction (LVEF) \>45%
• Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \>50%
• Negative HIV serology
• Negative pregnancy test: Confirmation per negative serum β-human chorionic gonadotropin (β-hCG)
• Willing to comply with all study procedures and be available for the duration of the study.