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| ID | Type | Description | Link |
|---|---|---|---|
| KD025-213 | Other Identifier | Kadmon | |
| U1111-1279-2518 | Registry Identifier | ICTRP | |
| DRI17633 | Other Identifier | Sanofi Identifier |
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The sponsor has decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.
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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
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:
With Amendment 2, the sample size was increased from approximately 126 subjects, with additional subjects to be enrolled as follows:
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 Subjects who have not achieved a response after 12 cycles of belumosudil should be withdrawn if in the Investigator's judgment there is no evidence of clinical benefit.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: belumosudil 200 mg, QD, adult arm | Experimental | Eligible subjects randomized to arm A will take belumosudil 200 mg once daily |
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| Arm B: belumosudil 200 mg, BID, adult arm | Experimental | Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily |
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| Adolescent arm A: belumosudil 200 mg QD | Experimental | Eligible subjects randomized to arm A will take belumosudil 200 mg once daily |
|
| Adolescent arm B: belumosudil 200 mg BID | Experimental | Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil (KD025) | Drug | Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The ORR was defined as the percentage of participants with a best response meeting the overall response criteria assessment of complete response (CR) or partial response (PR) at any post-baseline response assessment. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. Responses were assessed by the 2014 National Institutes of Health (NIH) Consensus Development Project on Clinical Trials in cGVHD. | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to Lack of response [LR]). CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. LR included the response status of mixed, unchanged, or progression. Mixed LR was defined as complete or partial response in at least one organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet the criteria for complete response, partial response, progression or mixed response. Progression LR-P was defined as progression in at least one organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital Site Number : 154 | Phoenix | Arizona | 85016 | United States | ||
| University of Arizona - Cancer Center Site Number : 122 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35135839 | Background | 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. | |
| 40311075 |
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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.
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156 participants were randomized in the adult cohort, 4 of which did not receive treatment. 3 participants were randomized in the adolescent cohort. The sponsor decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.
The study was conducted at 33 centers in the United States. A total of 251 participants were screened between 11 October 2018 to 08 August 2023, of which 92 participants were screen failures in adult cohort due to not meeting eligibility criteria, there were no screen failures in adolescent cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 milligram (mg) tablet orally once a day (QD) in 28-day cycles until clinically significant progression of chronic graft versus host disease (cGVHD), histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2023 | Sep 26, 2024 |
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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
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|
| From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by chronic GVHD. It consists of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question is scored 0, 1, 2, 3 or 4. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A summary score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing. A higher score indicated more bothersome symptoms. A 7-point difference on the summary score of cGVHD symptom scale was found to be clinically meaningful. | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
| Number of Participants With Best Response by Organ System | The best response (CR, PR) for individual organs (skin, eyes, mouth, esophagus, upper gastrointestinal [GI], lower GI, liver, lungs, joints and fascia) were summarized. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Percentage of Participants With Best Response of PR and CR | PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Responses were assessed by the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD. | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Change in corticosteroid doses was analyzed by using prednisone dose equivalents. If participants were not using prednisone as the systemic corticosteroid, then the prednisone dose equivalent would be determined according to following conversion ratios: 1 mg prednisone is equivalent to: 4.0 mg Hydrocortisone; 0.8 mg Methylprednisolone; 0.15 mg Dexamethasone; 1.0 mg Prednisolone and 0.8 mg Triamcinolone. | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms |
| Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose | Calcineurin inhibitors include systemic tacrolimus and cyclosporine. Percentage of participants with reduction and discontinuation of calcineurin inhibitor dose is presented. | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
| Failure-Free Survival (FFS) | FFS was defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy (i.e. underlying disease) and was censored by last response assessment or long term follow up assessment, whichever was the latest and available. | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Overall Survival (OS) | OS was defined as time from first dose of belumosudil to the date of death due to any cause. | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment | The Clinician-reported global cGVHD Activity Assessment is a 0-10 point numeric rating scale with a score of 0 indicating "cGVHD symptoms not at all severe" and a score of 10 being "most severe cGVHD symptoms possible". Higher scores indicated worse symptoms. Best response was defined as PR+CR. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Participants were categorized in 3 categories at baseline based on the global severity scores of <6, =6-7 and >7 and number of participants with best response for them is reported. | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
| Change From Baseline in Patient Self-Reported Symptom Activity Based on cGVHD Activity Assessment | The symptom activity item is a 0-10-point numeric rating scale with a score of 0 indicating "cGVHD symptoms not at all severe" and a score of 10 being "most severe cGVHD symptoms possible". The status reported by participants were categorized as none, mild, moderate, and severe. Higher scores indicated worse symptoms. Baseline was defined as the valid and last non-missing value obtained within 14 days prior to participants receiving the first study drug. | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms |
| Maximum Concentration Observed (Cmax) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate Cmax of belumosudil. As pre-specified in protocol, pharmacokinetic (PK) parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
| Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate Tmax of belumosudil. As pre-specified in protocol, PK parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
| Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate AUC0-6 of belumosudil. As pre-specified in protocol, PK parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
| Time to Response (TTR) | TTR was measured as the time from first treatment to the time of first documentation of response. | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first(maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Time to Next Treatment (TTNT) | The TTNT was measured as the time from first treatment to the time of new systemic cGVHD treatment, censored by last response assessment or long term follow up assessment, whichever was the latest and available. | From first dose of study drug to the time of new treatment or censoring date, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| Tucson |
| Arizona |
| 85724 |
| United States |
| City of Hope Medical Center Site Number : 050 | Duarte | California | 91010 | United States |
| University of California, Los Angeles (UCLA) - Medical Center Site Number : 104 | Los Angeles | California | 90059 | United States |
| University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center Site Number : 058 | San Francisco | California | 94143 | United States |
| Stanford Cancer Center Site Number : 108 | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute Site Number : 098 | Denver | Colorado | 80218 | United States |
| University of Miami - Sylvester Cancer Center Site Number : 097 | Miami | Florida | 33136 | United States |
| Moffitt Site Number : 102 | Tampa | Florida | 33612 | United States |
| Emory University School of Medicine Site Number : 100 | Atlanta | Georgia | 30322 | United States |
| Augusta University Medical Center Site Number : 093 | Augusta | Georgia | 30912 | United States |
| University of Illinois at Chicago Site Number : 139 | Chicago | Illinois | 60612 | United States |
| University of Iowa Site Number : 126 | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center Site Number : 105 | Fairway | Kansas | 66205 | United States |
| Center for Cancer Research National Cancer Institute Site Number : 107 | Bethesda | Maryland | 20892-1203 | United States |
| Massachusetts General Hospital Site Number : 002 | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute Site Number : 004 | Boston | Massachusetts | 02215 | United States |
| CS Mott Children's Hospital Site Number : 157 | Ann Arbor | Michigan | 48109-5718 | United States |
| Barbara Ann Karmanos Cancer Institute-4100 John R St Site Number : 094 | Detroit | Michigan | 48201 | United States |
| University of Minnesota Site Number : 051 | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine Site Number : 125 | St Louis | Missouri | 63110 | United States |
| University of Rochester Site Number : 106 | Rochester | New York | 14642 | United States |
| Wake Forest Site Number : 123 | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation Site Number : 041 | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital & Wexner Medical Center at the Ohio State University Comprehensive Cancer Center Site Number : 103 | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University (OHSU) Site Number : 095 | Portland | Oregon | 97239-3098 | United States |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Site Number : 132 | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon and HCA Research Institute Site Number : 007 | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center Site Number : 063 | Nashville | Tennessee | 37232-6868 | United States |
| South Austin Medical Center Site Number : 091 | Austin | Texas | 78704 | United States |
| MD Anderson Cancer Center Site Number : 057 | Houston | Texas | 77030-4009 | United States |
| Texas Transplant Institute Site Number : 079 | San Antonio | Texas | 78229 | United States |
| Fred Hutchinson Cancer Research Center Site Number : 052 | Seattle | Washington | 98109 | United States |
| University of Wisconsin - Carbone Cancer Center Site Number : 135 | Madison | Wisconsin | 53792 | United States |
| Froedtert Hospital and the Medical College of Wisconsin Site Number : 101 | Milwaukee | Wisconsin | 53226 | United States |
| Derived |
| Sharma R, Holtzman NG, Pusic I, Cutler C, Treister N, Mehta RS, Alousi AS, Vigneswaran N, Javaid A, Boksa F, Mody DP, Costa-da-Silva AC, Schueller O, Mace S, Yao Y, Ji R, Hu B, Marshall K, Blazar BR, Lee SJ, Pavletic SZ, Mays JW. Belumosudil reduces oral chronic graft-versus-host disease tissue inflammation and fibrosis: a ROCKstar companion study. Blood Adv. 2025 Jul 22;9(14):3479-3494. doi: 10.1182/bloodadvances.2025016170. |
| 35781099 | Derived | 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. |
| 34265047 | Derived | 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. |
| FG001 | Adult Arm B: Belumosudil 200 mg BID | Participants belumosudil 200 mg tablet orally twice a day (BID) in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| FG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| FG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| COMPLETED |
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| NOT COMPLETED |
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Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| BG001 | Adult Arm B: Belumosudil 200 mg BID | Participants belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| BG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| BG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Overall Response Rate (ORR) | The ORR was defined as the percentage of participants with a best response meeting the overall response criteria assessment of complete response (CR) or partial response (PR) at any post-baseline response assessment. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. Responses were assessed by the 2014 National Institutes of Health (NIH) Consensus Development Project on Clinical Trials in cGVHD. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Duration of Response (DOR) | DOR is defined as the time from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to Lack of response [LR]). CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. LR included the response status of mixed, unchanged, or progression. Mixed LR was defined as complete or partial response in at least one organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet the criteria for complete response, partial response, progression or mixed response. Progression LR-P was defined as progression in at least one organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method. | Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment. | Posted | Median | 95% Confidence Interval | Weeks | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by chronic GVHD. It consists of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question is scored 0, 1, 2, 3 or 4. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A summary score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing. A higher score indicated more bothersome symptoms. A 7-point difference on the summary score of cGVHD symptom scale was found to be clinically meaningful. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
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| Secondary | Number of Participants With Best Response by Organ System | The best response (CR, PR) for individual organs (skin, eyes, mouth, esophagus, upper gastrointestinal [GI], lower GI, liver, lungs, joints and fascia) were summarized. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected for each specified category are reported. | Posted | Count of Participants | Participants | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Percentage of Participants With Best Response of PR and CR | PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Responses were assessed by the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Change in corticosteroid doses was analyzed by using prednisone dose equivalents. If participants were not using prednisone as the systemic corticosteroid, then the prednisone dose equivalent would be determined according to following conversion ratios: 1 mg prednisone is equivalent to: 4.0 mg Hydrocortisone; 0.8 mg Methylprednisolone; 0.15 mg Dexamethasone; 1.0 mg Prednisolone and 0.8 mg Triamcinolone. | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected at specified timepoints are reported. | Posted | Median | Full Range | Percent change | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms |
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| Secondary | Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose | Calcineurin inhibitors include systemic tacrolimus and cyclosporine. Percentage of participants with reduction and discontinuation of calcineurin inhibitor dose is presented. | mITT population included all randomized participants who received at least one dose of study drug. Only those participants who received CNI at baseline were included in the analysis. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
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| Secondary | Failure-Free Survival (FFS) | FFS was defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy (i.e. underlying disease) and was censored by last response assessment or long term follow up assessment, whichever was the latest and available. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Overall Survival (OS) | OS was defined as time from first dose of belumosudil to the date of death due to any cause. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment | The Clinician-reported global cGVHD Activity Assessment is a 0-10 point numeric rating scale with a score of 0 indicating "cGVHD symptoms not at all severe" and a score of 10 being "most severe cGVHD symptoms possible". Higher scores indicated worse symptoms. Best response was defined as PR+CR. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Participants were categorized in 3 categories at baseline based on the global severity scores of <6, =6-7 and >7 and number of participants with best response for them is reported. | mITT population included all randomized participants who received at least one dose of study drug. Only participants with respective global severity rating score categories of <6, =6-7 and >7 assessed at baseline are reported. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms |
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| Secondary | Change From Baseline in Patient Self-Reported Symptom Activity Based on cGVHD Activity Assessment | The symptom activity item is a 0-10-point numeric rating scale with a score of 0 indicating "cGVHD symptoms not at all severe" and a score of 10 being "most severe cGVHD symptoms possible". The status reported by participants were categorized as none, mild, moderate, and severe. Higher scores indicated worse symptoms. Baseline was defined as the valid and last non-missing value obtained within 14 days prior to participants receiving the first study drug. | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms |
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| Secondary | Maximum Concentration Observed (Cmax) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate Cmax of belumosudil. As pre-specified in protocol, pharmacokinetic (PK) parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
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| Secondary | Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate Tmax of belumosudil. As pre-specified in protocol, PK parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Posted | Median | Full Range | Hours | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
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| Secondary | Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil | Blood samples were collected at the specified timepoints to evaluate AUC0-6 of belumosudil. As pre-specified in protocol, PK parameters were only calculated for participants with full PK samples. Thus, PK parameters were not calculated for adolescent participants who only had sparse PK samples. | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*ng/mL | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms |
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| Secondary | Time to Response (TTR) | TTR was measured as the time from first treatment to the time of first documentation of response. | Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment. | Posted | Median | Full Range | Weeks | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first(maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
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| Secondary | Time to Next Treatment (TTNT) | The TTNT was measured as the time from first treatment to the time of new systemic cGVHD treatment, censored by last response assessment or long term follow up assessment, whichever was the latest and available. | mITT population included all randomized participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From first dose of study drug to the time of new treatment or censoring date, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) |
|
Treatment-emergent adverse events (TEAEs): From first dose of study drug to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms). All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to end of study, approximately 62 months.
Safety population included all randomized participants who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinicallysignificant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptabletoxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). | 14 | 77 | 36 | 77 | 73 | 77 |
| EG001 | Adult Arm B: Belumosudil 200 mg BID | Participants belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significantprogression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity,Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). | 14 | 75 | 30 | 75 | 73 | 75 |
| EG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). | 0 | 2 | 1 | 2 | 2 | 2 |
| EG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinicallysignificant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptabletoxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis Orbital | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Large Intestine Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Acute Myeloid Leukaemia Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Microangiopathic Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemic Hyperosmolar Nonketotic Syndrome | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Steroid Diabetes | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Enterovesical Fistula | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumatosis Intestinalis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Liver Function Test Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Candida Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cytomegalovirus Infection Reactivation | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Molluscum Contagiosum | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oesophageal Obstruction | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis Psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Knee Deformity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Premature Menopause | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Bicarbonate Decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Cholesterol Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram Qt Prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
The sponsor decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 ext 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2020 | Sep 26, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718240 | belumosudil |
| C000619755 | KD025 |
Not provided
Not provided
Not provided
| 18-77 Years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Adult Arm B: Belumosudil 200 mg BID | Participants belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| Adult Arm B: Belumosudil 200 mg BID |
Participants belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 |
| Adolescent Arm A: Belumosudil 200 mg QD |
Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| Adult Arm B: Belumosudil 200 mg BID |
Participants belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 | Adolescent Arm A: Belumosudil 200 mg QD | Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
|
| OG002 |
| Adolescent Arm A: Belumosudil 200 mg QD |
Participants received belumosudil 200 mg tablet orally QD in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
| OG003 | Adolescent Arm B: Belumosudil 200 mg BID | Participants received belumosudil 200 mg tablet orally BID in 28-day cycles until clinically significant progression of cGVHD, histologic recurrence of underlying malignancy, unacceptable toxicity, Investigator decision, participant preference/withdrawal of consent, loss of follow-up, sponsor decision, or death (whichever occurred first). |
|
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