NCT05621759

Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

Phase II Single-Arm Open-Label Study Of Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus for the Prevention of Graft-Versus-Host Disease (GVHD) Following Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open label, phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive dosed reduced cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Nitrogen mustard alkylating agent produced by Bristol-Myers Squibb.
DRUG	Abatacept	Calcineurin-inhibitor produced by Astellas.
DRUG	Tacrolimus	Selective T cell co-stimulation modulator produced by Bristol-Myers Squibb.

Timeline

• Start date: 2022-09-07
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2022-11-18
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study