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Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease

Status
Active
Cancer Type
Graft Versus Host Disease
Trial Phase
Phase II
Eligibility
18 Years and older (Adult, Older Adult ), Male and Female
Study Type
Treatment
NCT ID
NCT06046248
Protocol IDs
NSH 1385 (primary)
Study Sponsor
Northside Hospital, Inc.

Summary

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Eligibility

Inclusion Criteria:

  • First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
  • Previously untreated, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
  • KPS >/= 70%
  • Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm#

Exclusion Criteria:

  • Late persistent or recurrent aGVHD
  • Active uncontrolled infection
  • History of HIV infection
  • Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
  • Calculated CrCl <30mL/min
  • AST and/or ALT >5x ULN or direct bilirubin >3x ULN
  • Cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
  • Has received more than one allogeneic transplant prior to the occurrence of cGVHD

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


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