Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Description

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

Conditions

Chronic Graft Versus Host Disease

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Study Overview

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Study Details

Study overview

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

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

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Condition
Chronic Graft Versus Host Disease
Intervention / Treatment

-

Contacts and Locations

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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#
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northside Hospital, Inc.,

Scott Solomon, MD, PRINCIPAL_INVESTIGATOR, BMTGA/Northside Hospital

Study Record Dates

2027-12-31