RECRUITING

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

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Conditions

Chronic Graft Versus Host Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-29
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06046248

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
  2. * Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
  3. * KPS \>/= 70%
  4. * 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#
  1. * Late persistent or recurrent aGVHD
  2. * Active uncontrolled infection
  3. * History of HIV infection
  4. * 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.
  5. * Calculated CrCl \<30mL/min
  6. * AST and/or ALT \>5x ULN or direct bilirubin \>3x ULN
  7. * Cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
  8. * Has received more than one allogeneic transplant prior to the occurrence of cGVHD

Contacts and Locations

Study Contact

Scott Solomon, MD
CONTACT
404-255-1930
ssolomon@bmtga.com
Caitlin Guzowski, MBA, MHA
CONTACT
404-851-8523
caitlin.guzowski@northside.com

Principal Investigator

Scott Solomon, MD
PRINCIPAL_INVESTIGATOR
BMTGA/Northside Hospital

Study Locations (Sites)

Northside Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Northside Hospital, Inc.

  • Scott Solomon, MD, PRINCIPAL_INVESTIGATOR, BMTGA/Northside Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-29
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-01-29
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Graft Versus Host Disease