Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation
Summary
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.
Arms & interventions
- DrugBelumosudil
Belumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)
Outcome measures
Primary
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
The primary objective is to assess the efficacy of belumosudil in the improvement of GRFS at 1-year post-HCT for patients receiving PTCY GVHD prophylaxis and separately for participants receiving CNI-based (CNI without PTCY) plus abatacept GVHD prophylaxis.
Time frame: 1 year
Eligibility criteria
Study locations (8)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
New York University (Data Collection Only)
New York, New York, 10010
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553