Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Chronic Graft-versus-host-disease Clinical Trial

Official title:

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05305989
• Other study ID #: LTS17660
• Secondary ID: KD025-217
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 23, 2022
• Est. completion date: July 10, 2024

Study information

• Verified date: August 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

Description:

This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not be screened. Subjects who have signed the informed consent form will be enrolled in Study KD025-217 if they have met 1 of the following conditions:

• Actively receiving belumosudil or in long-term follow-up (LTFU) in Study KD025-208 or Study KD025-213

• Enrolled in the Companion Study as specified in Study KD025-213 Amendment 2 and received at least 6 months of treatment or is in LTFU

Approximately 20 Study Centers will participate with approximately 70 subjects participating overall.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must have been treated with belumosudil for at least 1 of the following:

• Actively receiving belumosudil on Study KD025-208 or Study KD025-213

• Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs.

• Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU

Exclusion Criteria:

• Female subject who is pregnant or breastfeeding

• Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft-versus-host-disease
• Graft vs Host Disease

Intervention

Drug:
• Belumosudil 200 mg QD
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
• Belumosudil 200 mg BID
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
• Belumosudil 400 mg QD
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.

Locations

Country	Name	City	State
United States	St. David's South Austin Medical Center_Site number 091	Austin	Texas
United States	City of Hope National Medical Center_Site number 050	Duarte	California
United States	MD Anderson Cancer Center_Site number 057	Houston	Texas
United States	University of Pittsburgh Medical Center Hillman Cancer Center_Site number 132	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine_Site number 125	Saint Louis	Missouri
United States	Texas Transplant Institute_Site number 079	San Antonio	Texas
United States	Fred Hutchinson Cancer Research Center_Site number 052	Seattle	Washington
United States	Stanford Cancer Center_Site number 108	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Kadmon, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Evaluating safety longitudinally	3 years
Primary	Duration of Response	The time from initial response of PR or CR until documents progression of cGVHD; evaluating efficacy longitudinally.	3 years
Primary	Failure Free Survival	FFS is defined as the absence of cGVHD treatment change, non-relapse mortality and recurrent malignancy; evaluating efficacy longitudinally.	3 years
Secondary	Grade = 3 Adverse Events		3 years
Secondary	Serious Adverse Events		3 years
Secondary	Deaths		3 years
Secondary	Change in Lee Symptom Scale Score: Number of subjects with a =7 point reduction/=7 point reduction on 2 consecutive assessments	Symptom burden will be assessed on Day 1 of each cycle starting on Cycle 1 Day 1, as well as at the EOT visit. The questionnaire asks subjects to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by chronic GVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician assessment specifically for each of affected organ as a Complete Response, Partial Response or Progression	3 years
Secondary	Change in Lee Symptom Scale Score: Duration of a =7 point reduction	Symptom burden will be assessed on Day 1 of each cycle starting on Cycle 1 Day 1, as well as at the EOT visit. The questionnaire asks subjects to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by chronic GVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician assessment specifically for each of affected organ as a Complete Response, Partial Response or Progression	3 years
Secondary	Overall Survival	Time from first dose of belumosudil to the date of death due to any cause.	3 years
Secondary	Percentage of subjects who have a best response of PR or CR		3 years
Secondary	Response by individual organ based on the Clinician-reported Global cGVHD Activity Assessment	The response assessment for the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia).	3 years
Secondary	Change in corticosteroid dose		3 years
Secondary	Change in cGVHD Global Severity Rating using the Clinician-reported Global cGVHD Activity Assessment (Appendix B: Clinician-reported Global cGVHD Activity Assessment)	Physician-reported outcome. The global severity rating has a scale of 0-10, 0 being cGVHD symptoms not at all severe, 10 being most severe cGVHD symptoms possible.	3 years