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ACTIVE NOT RECRUITING
NCT05289167
PHASE1/PHASE2

Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2022-03-13

Completion Date

2027-12

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

50 mg/kg IV over 1 hour on Day +3 and +4

DRUG

Abatacept

Dose level 0: 10 mg/kg IV over 30 minutes on day +5 Dose level 1: 10mg/kg IV over 30 minutes on day +5 and +14 Dose level 2: 10mg/kg IV over 30 minutes on day +5, +14, and +28

DRUG

Bortezomib

1.3 mg/m2 IV 6 hours after graft infusion completion and 72 hours thereafter.

Locations (1)

Northwell Health

New Hyde Park, New York, United States