RECRUITING

Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Conditions

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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

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above. The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

Official Title

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Quick Facts

Study Start:2025-01-31

Study Completion:2025-08-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05567406

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:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants are included in the study if any of the following criteria apply: * Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification. * Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD. * Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening. * Have persistent cGVHD manifestations and systemic therapy is indicated. * Karnofsky (if aged ≥ 16 years) / Lansky (if aged \< 16 years) Performance Score of ≥ 60. * At least 12 years of age; weight ≥ 40 kilograms (kg). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN). * Total bilirubin ≤ 1.5 x ULN. * Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants * Capable of giving signed informed consent.	* Participants are excluded from the study if any of the following criteria apply: * Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted). * Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening. * Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment. * History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease). * Corrected QT interval using Fridericia's formula (QTc\[F\]) \> 480 ms. * Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Inclusion Criteria

Exclusion Criteria

* Participants are included in the study if any of the following criteria apply:
* Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
* Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
* Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
* Have persistent cGVHD manifestations and systemic therapy is indicated.
* Karnofsky (if aged ≥ 16 years) / Lansky (if aged \< 16 years) Performance Score of ≥ 60.
* At least 12 years of age; weight ≥ 40 kilograms (kg).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
* Total bilirubin ≤ 1.5 x ULN.
* Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants
* Capable of giving signed informed consent.

* Participants are excluded from the study if any of the following criteria apply:
* Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
* Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
* Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
* History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
* Corrected QT interval using Fridericia's formula (QTc\[F\]) \> 480 ms.
* Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610

Contact-US@sanofi.com

Principal Investigator

Clinical Sciences & Operations

STUDY_DIRECTOR

Sanofi

Study Locations (Sites)

Harvard Medical School - Massachusetts General Hospital (MGH) - Medical Practice Evaluation Center (MPEC)- Site Number : 002

Boston, Massachusetts, 02114

United States

Dana-Farber Cancer Institute- Site Number : 004

Boston, Massachusetts, 02215

United States

Washington University- Site Number : 125

Saint Louis, Missouri, 63110

United States

Texas Oncology - Dallas - Worth Street- Site Number : 126

Dallas, Texas, 75246

United States

Collaborators and Investigators

Sponsor: Kadmon, a Sanofi Company

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

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 Date2025-01-31

Study Completion Date2025-08-27

Study Record Updates

Study Start Date2025-01-31

Study Completion Date2025-08-27

Terms related to this study

Additional Relevant MeSH Terms

Chronic Graft Versus Host Disease