Clinical trial NCT05305989: Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
Official title: Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Graft-versus-host-disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Response (DOR)
timeFrame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
measure: Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS)
timeFrame: Baseline (Day 1) up to 23 months
measure: Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale
timeFrame: Baseline (Day 1) up to 23 months
measure: Time to Next Treatment (TTNT)
timeFrame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
measure: Failure-Free Survival (FFS)
timeFrame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
measure: Overall Survival (OS)
timeFrame: From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months
measure: Percentage of Participants With Complete Response (CR) and Partial Response (PR)
timeFrame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
measure: Number of Participants With Best Response by Organ System
timeFrame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
measure: Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction
timeFrame: Baseline (Day 1) and Month 23
measure: Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment
timeFrame: From Baseline (Day 1) up to 23 months
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths
timeFrame: From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Site Number : 050
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center Site Number : 108
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine Site Number : 125
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Site Number : 132
state: Pennsylvania
city: Austin
country: United States
facility: South Austin Medical Center Site Number : 091
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center Site Number : 057
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute Site Number : 079
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center Site Number : 052
state: Washington
Study officials:
References: