An open-label phase I study of JAK inhibitor ruxolitinib with and without CTLA-4 ig abatacept for the prophylaxis of graft-versus-host ddsease and cytokine release syndrome after T-cell replete haploidentical peripheral blood hematopoietic cell transplantation
Open-label trial demonstrates safety of ruxolitinib for preventing graft-versus-host disease and cytokine release syndrome in patients undergoing hemopoietic cell transplantation.
Key Points
This study aims to assess the safety of ruxolitinib alone and with abatacept in preventing graft-versus-host disease and cytokine release syndrome after transplantation.
Open-label phase I trial
Participants: patients with AML, ALL, MDS, or NHL undergoing peripheral blood haplo-transplantation
Comparative regimens: Ruxolitinib with or without abatacept, with traditional immunosuppressants
Endpoints: safety assessed by grade III-IV acute GVHD and non-relapse mortality
17 patients enrolled in Regimen 1 with successful engraftment
No cases of engraftment failure; short median times to neutrophil and platelet engraftment
Grade II acute GVHD incidence was 12.5% with no severe cases reported
No severe cytokine release syndrome observed; 80% had grade 1 CRS
Overall survival at day 180 was 78%, with no relapses reported