A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years-old at time of consent.
Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).
Recipients of 7-8/8 related or unrelated HLA-matched or related haploidentical donor.
Peripheral blood stem cell graft
Disqualifiers
Recipient of CD34+ selected or engineered stem cell graft.
Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).
Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
Pulmonary dysfunction with DLCO <50% corrected for hemoglobin
Trial design
Design model
Single group
Treatments tested in this trial
Belumosudil
DrugBelumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Participants with hematologic malignancy in morphologic remissionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSponsors and contacts
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Source ClinicalTrials.gov