A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Northwell Health

Summary

Description

The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants. Adult patients 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 stan…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Age ≥18 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) * ALP ≤250 IU/L * LVEF \>45% * Adjusted DLCO \>50% * Negative HIV serology * Negative pregnancy test: Confirmation per negative serum β-hCG * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * Pregnant or nursing females or women of repro…

Interventions

Drug
Cyclophosphamide, Bortezomib, Abatacept
Drug given for prevention of Graft-versus-Host Disease (GvHD) following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Location

Zuckerberg Cancer Center
Lake Success, New York