drugset / Trial / NCT04961801

Acalabrutinib for GVHD Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation in Lymphomas and Leukemia

NCT04961801

NaSequentialOpen-labelTreatment

Summary

GVHD remains a major cause of morbidity and mortality following SCT. The current standard of care for prophylaxis against GVHD includes tacrolimus and methotrexate. This study proposes to utilize acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, for GVHD prophylaxis following allogeneic SCT. The hypothesis is that the addition of acalabrutinib to our institutional standard GVHD prophylaxis (tacrolimus and methotrexate) is safe, feasible, and effective in reducing both the incidence and severity of acute GVHD.

Timeline

Start
2022-03
Primary completion
2026-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule
Background Methotrexate Small molecule
Background Tacrolimus Small molecule

Indications