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

Primary Purpose

Chronic Graft-versus-host-disease

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Belumosudil 200 mg QD
Belumosudil 200 mg BID
Belumosudil 400 mg QD
Sponsored by
Kadmon, a Sanofi Company
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:

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

Sites / Locations

  • City of Hope National Medical Center_Site number 050
  • Stanford Cancer Center_Site number 108
  • Washington University School of Medicine_Site number 125
  • University of Pittsburgh Medical Center Hillman Cancer Center_Site number 132
  • St. David's South Austin Medical Center_Site number 091
  • MD Anderson Cancer Center_Site number 057
  • Texas Transplant Institute_Site number 079
  • Fred Hutchinson Cancer Research Center_Site number 052

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A: belumosudil 200 mg QD

Arm B: belumosudil 200 mg BID

Arm C: belumosudil 400 mg QD

Arm Description

The assigned arm is per the previous study KD025-213 or study KD025-208

The assigned arm is per the previous study KD025-213 or study KD025-208

The assigned arm is per the previous study KD025-213 or study KD025-208

Outcomes

Primary Outcome Measures

Adverse Events
Evaluating safety longitudinally
Duration of Response
The time from initial response of PR or CR until documents progression of cGVHD; evaluating efficacy longitudinally.
Failure Free Survival
FFS is defined as the absence of cGVHD treatment change, non-relapse mortality and recurrent malignancy; evaluating efficacy longitudinally.

Secondary Outcome Measures

Grade ≥ 3 Adverse Events
Serious Adverse Events
Deaths
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
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
Overall Survival
Time from first dose of belumosudil to the date of death due to any cause.
Percentage of subjects who have a best response of PR or CR
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).
Change in corticosteroid dose
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.

Full Information

First Posted
February 2, 2022
Last Updated
August 24, 2023
Sponsor
Kadmon, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05305989
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: belumosudil 200 mg QD
Arm Type
Experimental
Arm Description
The assigned arm is per the previous study KD025-213 or study KD025-208
Arm Title
Arm B: belumosudil 200 mg BID
Arm Type
Experimental
Arm Description
The assigned arm is per the previous study KD025-213 or study KD025-208
Arm Title
Arm C: belumosudil 400 mg QD
Arm Type
Experimental
Arm Description
The assigned arm is per the previous study KD025-213 or study KD025-208
Intervention Type
Drug
Intervention Name(s)
Belumosudil 200 mg QD
Other Intervention Name(s)
REZUROCK
Intervention Description
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Intervention Type
Drug
Intervention Name(s)
Belumosudil 200 mg BID
Other Intervention Name(s)
REZUROCK
Intervention Description
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Intervention Type
Drug
Intervention Name(s)
Belumosudil 400 mg QD
Other Intervention Name(s)
REZUROCK
Intervention Description
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Evaluating safety longitudinally
Time Frame
3 years
Title
Duration of Response
Description
The time from initial response of PR or CR until documents progression of cGVHD; evaluating efficacy longitudinally.
Time Frame
3 years
Title
Failure Free Survival
Description
FFS is defined as the absence of cGVHD treatment change, non-relapse mortality and recurrent malignancy; evaluating efficacy longitudinally.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Grade ≥ 3 Adverse Events
Time Frame
3 years
Title
Serious Adverse Events
Time Frame
3 years
Title
Deaths
Time Frame
3 years
Title
Change in Lee Symptom Scale Score: Number of subjects with a ≥7 point reduction/≥7 point reduction on 2 consecutive assessments
Description
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
Time Frame
3 years
Title
Change in Lee Symptom Scale Score: Duration of a ≥7 point reduction
Description
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
Time Frame
3 years
Title
Overall Survival
Description
Time from first dose of belumosudil to the date of death due to any cause.
Time Frame
3 years
Title
Percentage of subjects who have a best response of PR or CR
Time Frame
3 years
Title
Response by individual organ based on the Clinician-reported Global cGVHD Activity Assessment
Description
The response assessment for the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia).
Time Frame
3 years
Title
Change in corticosteroid dose
Time Frame
3 years
Title
Change in cGVHD Global Severity Rating using the Clinician-reported Global cGVHD Activity Assessment (Appendix B: Clinician-reported Global cGVHD Activity Assessment)
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
City of Hope National Medical Center_Site number 050
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Stanford Cancer Center_Site number 108
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington University School of Medicine_Site number 125
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Pittsburgh Medical Center Hillman Cancer Center_Site number 132
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
St. David's South Austin Medical Center_Site number 091
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
MD Anderson Cancer Center_Site number 057
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Institute_Site number 079
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center_Site number 052
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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