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

Primary Purpose

Chronic Graft Versus Host Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Belumosudil
Rituximab
Sponsored by
Northside Hospital, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belumosudil Plus Rituximab

Arm Description

Belumosudil plus Rituximab

Outcomes

Primary Outcome Measures

Number of patients who achieve partial and complete responses after treatment

Secondary Outcome Measures

Length of time patients remain on corticosteroid treatment
Number of patients who had treatment-related adverse events using CTCAE v5

Full Information

First Posted
September 14, 2023
Last Updated
September 21, 2023
Sponsor
Northside Hospital, Inc.
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT06046248
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northside Hospital, Inc.
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft Versus Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Belumosudil Plus Rituximab
Arm Type
Experimental
Arm Description
Belumosudil plus Rituximab
Intervention Type
Drug
Intervention Name(s)
Belumosudil
Intervention Description
200mg PO QD x 24 cycles (28-day cycle)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Primary Outcome Measure Information:
Title
Number of patients who achieve partial and complete responses after treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Length of time patients remain on corticosteroid treatment
Time Frame
2 years
Title
Number of patients who had treatment-related adverse events using CTCAE v5
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Solomon, MD
Phone
404-255-1930
Email
ssolomon@bmtga.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Guzowski, MBA, MHA
Phone
404-851-8523
Email
caitlin.guzowski@northside.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Solomon, MD
Organizational Affiliation
BMTGA/Northside Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Guzowski, MBA, MHA
Phone
404-851-8523
Email
caitlin.guzowski@northside.com
First Name & Middle Initial & Last Name & Degree
H. Kent Holland, MD
First Name & Middle Initial & Last Name & Degree
Asad Bashey, MD
First Name & Middle Initial & Last Name & Degree
Lawrence E Morris, MD
First Name & Middle Initial & Last Name & Degree
Scott Solomon, MD
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
First Name & Middle Initial & Last Name & Degree
Lizamarie Bachier-Rodriguez, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

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