Long-term outcome after allo-SCT: close follow-up on a large cohort treated with myeloablative regimens.
Y R Abou-Mourad, B C Lau, M J Barnett...
https://pubmed.ncbi.nlm.nih.gov/19597425Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06046248
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Led by Northside Hospital, Inc. · Updated on 2026-04-20
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Northside Hospital, Inc.
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the drugs belumosudil and rituximab as a first treatment for people with extensive chronic graft-versus-host disease (cGVHD). This Phase 2, open-label study focuses on patients experiencing their first episode of cGVHD that requires systemic immunosuppression. The study is sponsored by Northside Hospital, Inc. and aims to understand how well these treatments work and how safe they are over time. Participants will receive belumosudil taken orally at 200 mg once daily for 24 cycles of 28 days each. Alongside this, rituximab will be given through intravenous infusion at 375 mg/m2 weekly for the first four weeks, then once every three months for four additional doses. This combined treatment regimen is designed to be the primary therapy for their cGVHD. During the study, participants will be closely monitored for treatment response, including the number achieving partial or complete responses over two years. Researchers will also track how long patients remain on corticosteroid therapy and record any treatment-related side effects using standardized criteria. The study involves regular assessments of health status and treatment effects for a total duration of two years, ensuring comprehensive safety and efficacy evaluation.
CONDITIONS
Brief Title
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- First episode of systemic immunosuppression-requiring chronic graft-versus-host disease (cGVHD) defined as classic cGVHD by NIH criteria without acute features
- Previously untreated for cGVHD, with less than 10 days of corticosteroids or alternative systemic immunosuppressive agents started for new cGVHD diagnosis
- Karnofsky Performance Status (KPS) of 70% or higher
- Adequate hematologic function: absolute neutrophil count (ANC) greater than 750 cells/mm3 and platelets greater than 30,000 cells/mm3 independent of transfusions or growth factors for at least 7 days prior to study entry
You will not qualify if you...
- Late persistent or recurrent acute graft-versus-host disease (aGVHD)
- Active uncontrolled infection
- History of HIV infection
- Active hepatitis B or C infection; positive hepatitis B or C antibody requires negative PCR test prior to enrollment
- Calculated creatinine clearance (CrCl) less than 30 mL/min
- Liver enzymes AST and/or ALT greater than 5 times the upper limit of normal or direct bilirubin greater than 3 times the upper limit of normal
- Cardiac ejection fraction less than 40% or history of uncontrolled cardiac arrhythmias
- More than one prior allogeneic transplant before cGVHD occurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 24 cycles of 28 days each for Belumosudil, with Rituximab dosing over the initial weeks and continued doses at 3-month intervals.
Participants receive Belumosudil orally once daily in 28-day cycles and Rituximab intravenously weekly for 4 weeks, then every 3 months for 4 doses, as part of their treatment for chronic graft-versus-host disease.
Weekly visits for Rituximab infusions during the first 4 weeks, then visits every 3 months for additional Rituximab doses; daily oral medication for Belumosudil.
Trial Site Locations
Total: 1 location
1
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
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Research Team
S
Scott Solomon, MD
C
Caitlin Guzowski, MBA, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Late mortality after allogeneic hematopoietic cell transplantation and functional status of long-term survivors: report from the Bone Marrow Transplant Survivor Study.
Smita Bhatia, Liton Francisco, Andrea Carter...
https://pubmed.ncbi.nlm.nih.gov/17671231Long-term outcome of patients given transplants of mobilized blood or bone marrow: A report from the International Bone Marrow Transplant Registry and the European Group for Blood and Marrow Transplantation.
Norbert Schmitz, Mary Eapen, Mary M Horowitz...
https://pubmed.ncbi.nlm.nih.gov/16946302Chronic graft versus host disease.
Meghan A Higman, Georgia B Vogelsang
https://pubmed.ncbi.nlm.nih.gov/15142114Therapy for chronic graft-versus-host disease: a randomized trial comparing cyclosporine plus prednisone versus prednisone alone.
Sibel Koc, Wendy Leisenring, Mary E D Flowers...
https://pubmed.ncbi.nlm.nih.gov/12070007How I treat chronic graft-versus-host disease.
G B Vogelsang
https://pubmed.ncbi.nlm.nih.gov/11222360Chronic graft-versus-host disease: clinical manifestation and therapy.
V Ratanatharathorn, L Ayash, H M Lazarus...
https://pubmed.ncbi.nlm.nih.gov/11509929Quality of life following bone marrow transplantation: a comparison of patient reports with population norms.
H J Sutherland, G M Fyles, G Adams...
https://pubmed.ncbi.nlm.nih.gov/9193757Quality of life in 244 recipients of allogeneic bone marrow transplantation.
S Chiodi, S Spinelli, G Ravera...
https://pubmed.ncbi.nlm.nih.gov/10997973Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study.
Christopher J Fraser, Smita Bhatia, Kirsten Ness...
https://pubmed.ncbi.nlm.nih.gov/16788100