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RECRUITING
NCT06681922
PHASE1/PHASE2

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)

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-09-23

Completion Date

2027-10

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide, Bortezomib, Abatacept

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

Locations (1)

Zuckerberg Cancer Center

Lake Success, New York, United States