Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention

Summary

This is a single arm, open label, optimal 2-stage Simon design phase Ib-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 cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.

Timeline

Start

2020-09-16

Primary completion

2022-12-14

Completion

2024-08-15

Publications

• Al-Homsi AS, Cirrone F, Wo S, Cole K, Suarez-Londono JA, Gardner SL, Hsu J, Stocker K, Bruno B, Goldberg JD, Levinson BA, Abdul-Hay M. PTCy, abatacept, and a short course of tacrolimus for GVHD prevention after haploidentical transplantation. Blood Adv. 2023 Jul 25;7(14):3604-3611. doi: 10.1182/bloodadvances.2023010545.

Drugs

Indications