drugset / Trial / NCT05621759

Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

NCT05621759

Phase 2 Active not recruiting 27 enrolled NYU Langone Health
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2022-09-07
Primary completion
2027-01-30
Completion
2027-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 10 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 25 mg/kg Intravenous
Subject Tacrolimus Small molecule 0.02 mg/kg Intravenous