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Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Primary Purpose

Chronic Graft-versus-host-disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Belumosudil (KD025)
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

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

Inclusion Criteria:

  1. Male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
  2. Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
  3. Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
  4. Have persistent cGVHD manifestations and systemic therapy is indicated
  5. Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged < 16 years)
  6. Weight ≥ 40kg

Exclusion Criteria:

  1. Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
  2. Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
  3. Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.

Sites / Locations

  • University of Alabama at Birmingham - Children's of Alabama_Site number 156Recruiting
  • City of Hope National Medical Center_Site number 050Recruiting
  • University of California, Los Angeles_Site number 104
  • Children's Hospital of Orange County_Site number 165Recruiting
  • University of California, San Francisco_Site number 058
  • Stanford Cancer Center, Blood and Marrow Transplantation_Site number 108
  • Colorado Blood Cancer Institute_Site number 098
  • Children's National Medical Center_Site number 163Recruiting
  • University of Miami - Sylvester Cancer Center_Site number 097
  • H. Lee Moffitt Cancer Center & Research Institute_Site number 102
  • Emory University School of Medicine_Site number 100Recruiting
  • University of Illinois at Chicago_Site number 139
  • University of Kansas Cancer Center_Site number 105
  • National Cancer Institute_Site number 107
  • Massachusetts General Hospital_Site number 002
  • Dana Farber Cancer Institute_Site number 004Recruiting
  • Barbara Ann Karmanos Cancer Institute_Site number 094
  • University of Minnesota Medical Center, Fairview_Site number 051
  • Washington University School of Medicine, Division of Oncology_Site number 125Recruiting
  • Hackensack University Medical Center_Site number 162Recruiting
  • University of Rochester_Site number 106
  • Wake Forest Baptist Medical Center Wake Forest University School of Medicine_Site number 123
  • Cincinnati Children's Hospital Medical Center_Site number 151
  • The Cleveland Clinic Foundation_Site number 041Recruiting
  • The Ohio State University_Site number 103
  • Oregon Health & Science University - (enrolling 12-18 yrs)_Site number 095Recruiting
  • University of Pittsburgh Medical Center Hillman Cancer CenterSite number 132
  • Sarah Cannon Research Institute at Tennessee Oncology_Site number 007
  • Vanderbilt University Medical Center_Site number 063Recruiting
  • St. David's South Austin Medical Center_Site number 091
  • University of Texas Southwestern_Site number 155Recruiting
  • The University of Texas MD Anderson Cancer Center_Site number 057Recruiting
  • Texas Transplant Physician Group- Adult Blood & Marrow Transplant_Methodist Physician Practices, PLLC_Site number 079
  • Fred Hutch Cancer Research Center_Site number 052
  • University of Wisconsin -Carbone Cancer Center_Site number 135
  • Froedtert Hospital and the Medical College of Wisconsin_Site number 101

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: belumosudil 200 mg QD

Arm B: belumosudil 200 mg BID

Arm Description

Eligible subjects randomized to arm A will take belumosudil 200 mg once daily

Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
The primary endpoint is the ORR with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.

Secondary Outcome Measures

Duration of Response (DOR)
The time from initial response of PR or CR until documented progression of cGVHD
Change in Lee Symptom Scale Score
Analyses will include: Number of subjects with a ≥7 point reduction, Number of subjects with a ≥7 point reduction on 2 consecutive assessments and 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.
Response rate by organ system
The response assessment for the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia).
Percentage of subjects who have a best response of PR or CR
Change in corticosteroid dose
Change in calcineurin inhibitor dose
Failure-free survival (FFS)
FFS is defined as the absence of cGVHD treatment change, non-relapse mortality and recurrent malignancy. Median FFS (from first dose of belumosudil) and landmark FFS at 1 year will be analyzed.
Overall Survival (OS)
Time from first dose of belumosudil to the date of death due to any cause.
Change in cGVHD severity as based on the Physician-reported global cGVHD Activity Assessment
Physician-reported outcome
Change in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
Patient-reported outcome
Determine the Peak Plasma Concentration (Cmax) of belumosudil
Determine the maximum plasma concentration (Cmax) of belumosudil
Determine the observed time to reach peak plasma concentration (Tmax) of belumosudil
The time that belumosudil reach the maximum plasma concentration (Tmax).
Determine the half-life (T1/2) of belumosudil
The time it takes for half of belumosudil to be removed from plasma by biological processes (T1/2)
Determine the area under the plasma concentration versus time curve (AUC) of belumosudil
Area under the plasma concentration versus time curve (AUC)
Time to Response
The time it takes to obtain a cGVHD response to belumosudil.
Time to next treatment
The time it takes to initiate a new systemic cGVHD treatment after starting belumosudil.
Number pf participants with adverse event and serious adverse events
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital sign measurements, and ECG parameters.

Full Information

First Posted
August 13, 2018
Last Updated
August 1, 2023
Sponsor
Kadmon, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT03640481
Brief Title
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
Official Title
A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (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
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy
Detailed Description
Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy. Approximately 166 subjects with active cGVHD will be randomized (1:1) to receive treatment with one of two belumosudil (formerly known as KD025) regimens: Arm A: belumosudil 200 mg QD Arm B: belumosudil 200 mg BID With Amendment 2, the sample size was increased from approximately 126 subjects, with additional subjects to be enrolled as follows: 20 adolescents 20 adults into a site-specific Companion Study to collect biospecimens These additional subjects will also be randomized (1:1) to Arm A or Arm B. Any adolescent taking a proton pump inhibitor (PPI) or a strong CYP3A4 inducer will begin Cycle 1 Day 1 at the escalated dose of belumosudil 200 mg BID. Randomization will be stratified according to prior cGVHD treatment with ibrutinib (Yes / No) and severe cGVHD at baseline (Yes / No). Subjects may receive treatment in 28-day treatment cycles until clinically significant progression of cGVHD. Subjects who have not achieved a response after 12 cycles of belumosudil should be withdrawn if in the Investigator's judgment there is no evidence of clinical benefit. Subjects will undergo evaluations as outlined in the Study Assessments table (Appendix A). The primary endpoint is the overall response rate (ORR) with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in 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
Parallel Assignment
Model Description
Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: belumosudil 200 mg QD
Arm Type
Experimental
Arm Description
Eligible subjects randomized to arm A will take belumosudil 200 mg once daily
Arm Title
Arm B: belumosudil 200 mg BID
Arm Type
Experimental
Arm Description
Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Belumosudil (KD025)
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
Overall Response Rate (ORR)
Description
The primary endpoint is the ORR with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.
Time Frame
up to approximately 40 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
The time from initial response of PR or CR until documented progression of cGVHD
Time Frame
up to approximately 40 months
Title
Change in Lee Symptom Scale Score
Description
Analyses will include: Number of subjects with a ≥7 point reduction, Number of subjects with a ≥7 point reduction on 2 consecutive assessments and 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.
Time Frame
up to approximately 40 months
Title
Response rate by organ system
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
up to approximately 40 months
Title
Percentage of subjects who have a best response of PR or CR
Time Frame
up to approximately 40 months
Title
Change in corticosteroid dose
Time Frame
up to approximately 40 months
Title
Change in calcineurin inhibitor dose
Time Frame
up to approximately 40 months
Title
Failure-free survival (FFS)
Description
FFS is defined as the absence of cGVHD treatment change, non-relapse mortality and recurrent malignancy. Median FFS (from first dose of belumosudil) and landmark FFS at 1 year will be analyzed.
Time Frame
up to approximately 7 years
Title
Overall Survival (OS)
Description
Time from first dose of belumosudil to the date of death due to any cause.
Time Frame
up to approximately 7 years
Title
Change in cGVHD severity as based on the Physician-reported global cGVHD Activity Assessment
Description
Physician-reported outcome
Time Frame
up to approximately 40 months
Title
Change in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
Description
Patient-reported outcome
Time Frame
up to approximately 40 months
Title
Determine the Peak Plasma Concentration (Cmax) of belumosudil
Description
Determine the maximum plasma concentration (Cmax) of belumosudil
Time Frame
Pre-dose and post-dose sampling within 12 hours
Title
Determine the observed time to reach peak plasma concentration (Tmax) of belumosudil
Description
The time that belumosudil reach the maximum plasma concentration (Tmax).
Time Frame
Pre-dose and post-dose sampling within 12 hours
Title
Determine the half-life (T1/2) of belumosudil
Description
The time it takes for half of belumosudil to be removed from plasma by biological processes (T1/2)
Time Frame
Pre-dose and post-dose sampling within 12 hours
Title
Determine the area under the plasma concentration versus time curve (AUC) of belumosudil
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Pre-dose and post-dose sampling within 12 hours
Title
Time to Response
Description
The time it takes to obtain a cGVHD response to belumosudil.
Time Frame
up to approximately 40 months
Title
Time to next treatment
Description
The time it takes to initiate a new systemic cGVHD treatment after starting belumosudil.
Time Frame
up to approximately 40 months
Title
Number pf participants with adverse event and serious adverse events
Description
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital sign measurements, and ECG parameters.
Time Frame
Up to 28 days after the last dose of study treatment i.e., up to approximately 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT). 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 Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged < 16 years) Weight ≥ 40kg Exclusion Criteria: Subjects has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (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. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Facility Information:
Facility Name
University of Alabama at Birmingham - Children's of Alabama_Site number 156
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Goldman
Phone
205-934-5263
Email
fgoldman@peds.uab.edu
First Name & Middle Initial & Last Name & Degree
Jospeh Chewning
Facility Name
City of Hope National Medical Center_Site number 050
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Rosenthal, MD
Phone
626-930-5414
Email
jrosenth@coh.org
First Name & Middle Initial & Last Name & Degree
Amandeep Salhotra, MD
Facility Name
University of California, Los Angeles_Site number 104
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Orange County_Site number 165
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rishikesh Chavan
Phone
714-509-2769
Email
Rishikesh.chavan@choc.org
Facility Name
University of California, San Francisco_Site number 058
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Completed
Facility Name
Stanford Cancer Center, Blood and Marrow Transplantation_Site number 108
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Colorado Blood Cancer Institute_Site number 098
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Terminated
Facility Name
Children's National Medical Center_Site number 163
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Jacobsohn
Phone
202-476-5000
Email
dajacobs@childrensnational.org
Facility Name
University of Miami - Sylvester Cancer Center_Site number 097
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
H. Lee Moffitt Cancer Center & Research Institute_Site number 102
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Emory University School of Medicine_Site number 100
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Langston, MD
Phone
404-778-4236
Email
alangst@emory.edu
Facility Name
University of Illinois at Chicago_Site number 139
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kansas Cancer Center_Site number 105
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Institute_Site number 107
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital_Site number 002
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana Farber Cancer Institute_Site number 004
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Cutler, MD, MPH
Phone
617-632-3470
Email
Corey_Cutler@dfci.harvard.edu
Facility Name
Barbara Ann Karmanos Cancer Institute_Site number 094
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Minnesota Medical Center, Fairview_Site number 051
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington University School of Medicine, Division of Oncology_Site number 125
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenoy Shalini
Phone
314-454-6018
Email
shalinishenoy@wustl.edu
First Name & Middle Initial & Last Name & Degree
Iskra Pusic
Facility Name
Hackensack University Medical Center_Site number 162
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Krajewski
Phone
551-996-5600
Email
jennifer.krajewski@hmhn.org
First Name & Middle Initial & Last Name & Degree
Alfred Gillio
Facility Name
University of Rochester_Site number 106
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wake Forest Baptist Medical Center Wake Forest University School of Medicine_Site number 123
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Completed
Facility Name
Cincinnati Children's Hospital Medical Center_Site number 151
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Completed
Facility Name
The Cleveland Clinic Foundation_Site number 041
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hanna
Phone
216-444-2946
Email
hannar2@ccf.org
First Name & Middle Initial & Last Name & Degree
Rabi Hanna
Facility Name
The Ohio State University_Site number 103
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University - (enrolling 12-18 yrs)_Site number 095
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Information Line
Phone
503-494-1080
Email
hulmer@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Levanto Schachter
Facility Name
University of Pittsburgh Medical Center Hillman Cancer CenterSite number 132
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology_Site number 007
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Vanderbilt University Medical Center_Site number 063
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Kitko, MD
Phone
615-936-1762
Email
carrie.l.kitko@vumc.org
Facility Name
St. David's South Austin Medical Center_Site number 091
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Texas Southwestern_Site number 155
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Aquino
Phone
214-648-3896
Email
victor.aquino@utsouthwestern.edu
Facility Name
The University of Texas MD Anderson Cancer Center_Site number 057
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohtesh Mehta, MD
Phone
713-792-2808
Email
rmehta1@mdanderson.org
Facility Name
Texas Transplant Physician Group- Adult Blood & Marrow Transplant_Methodist Physician Practices, PLLC_Site number 079
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fred Hutch Cancer Research Center_Site number 052
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Wisconsin -Carbone Cancer Center_Site number 135
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Froedtert Hospital and the Medical College of Wisconsin_Site number 101
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
Citations:
PubMed Identifier
35135839
Citation
Przepiorka D, Le RQ, Ionan A, Li RJ, Wang YH, Gudi R, Mitra S, Vallejo J, Okusanya OO, Ma L, Yang Y, Patel P, Mezaache D, Shah R, Banerjee A, McLamore S, Maung AN, Goldberg KB, Pazdur R, Theoret MR, De Claro RA. FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy. Clin Cancer Res. 2022 Jun 13;28(12):2488-2492. doi: 10.1158/1078-0432.CCR-21-4176.
Results Reference
background
PubMed Identifier
35781099
Citation
Lee SJ, Cutler C, Blazar BR, Tu A, Yang Z, Pavletic SZ. Correlation of Patient-Reported Outcomes with Clinical Organ Responses: Data from the Belumosudil Chronic Graft-versus-Host Disease Studies. Transplant Cell Ther. 2022 Oct;28(10):700.e1-700.e6. doi: 10.1016/j.jtct.2022.06.020. Epub 2022 Jul 1.
Results Reference
derived
PubMed Identifier
34265047
Citation
Cutler C, Lee SJ, Arai S, Rotta M, Zoghi B, Lazaryan A, Ramakrishnan A, DeFilipp Z, Salhotra A, Chai-Ho W, Mehta R, Wang T, Arora M, Pusic I, Saad A, Shah NN, Abhyankar S, Bachier C, Galvin J, Im A, Langston A, Liesveld J, Juckett M, Logan A, Schachter L, Alavi A, Howard D, Waksal HW, Ryan J, Eiznhamer D, Aggarwal SK, Ieyoub J, Schueller O, Green L, Yang Z, Krenz H, Jagasia M, Blazar BR, Pavletic S. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021 Dec 2;138(22):2278-2289. doi: 10.1182/blood.2021012021. Erratum In: Blood. 2022 Mar 17;139(11):1772.
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Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

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