MT2018-35 A Randomized Phase 2 Study of Obinutuzumab for Prevention of Chronic Graft vs. Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation
This is a prospective, multicenter, randomized phase II trial of prophylactic obinutuzumab vs. placebo for prevention of chronic Graft vs. Host Disease (cGVHD) after Hematopoietic Cell Transplantation (HCT). A single dose of obinutuzumab or placebo will be administered prophylactically at 3, 6, 9 and 12 months after HCT. Clinical and immunological endpoints are measured sequentially. 200 subjects will be randomized and analyzed in a modified intention-to-treat fashion. The primary objective is to determine the effect of obinutuzumab prophylaxis on the incidence of corticosteroid-requiring cGVHD after allogeneic HCT. The primary endpoint of this phase II trial is the rate of corticosteroid-requiring cGVHD one year after HCT.
Graft vs. Host Disease
Clinics and Surgery Center (CSC), Graft vs. Host Disease