Clinical trial NCT06046248: Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Official title: Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Graft Versus Host Disease
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2023-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Number of patients who achieve partial and complete responses after treatment
timeFrame: 2 years
Secondary outcomes:
measure: Length of time patients remain on corticosteroid treatment
timeFrame: 2 years
measure: Number of patients who had treatment-related adverse events using CTCAE v5
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: BMTGA/Northside Hospital
name: Scott Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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