Trial Outcomes & Findings for Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (NCT NCT03640481)

Last Updated: 2024-12-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

159 participants

Primary outcome timeframe

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)

Results posted on

2024-12-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).	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).	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).	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).
Overall Study STARTED	78	78	2	1
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	78	78	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).	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).	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).
Overall Study Death	14	14	0	0
Overall Study Lost to Follow-up	2	0	0	0
Overall Study Site terminated by sponsor	1	3	0	0
Overall Study Study terminated by sponsor	29	42	1	0
Overall Study Withdrawal by Subject	5	4	0	1
Overall Study Other	26	12	1	0
Overall Study Randomized, but not treated	1	3	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).	Total n=155 Participants Total of all reporting groups
Age, Customized 12-17 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Age, Customized 18-77 Years	77 Participants n=5 Participants	75 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	152 Participants n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	38 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	37 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	88 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	67 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	134 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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)

Population: mITT population included all randomized participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Overall Response Rate (ORR)	74.0 Percentage of participants	76.0 Percentage of participants	50.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Population: Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=57 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=57 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=1 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Duration of Response (DOR)	23.9 Weeks Interval 11.43 to 50.43	32.0 Weeks Interval 20.86 to 53.14	16.1 Weeks NA indicates that confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.	4.1 Weeks NA indicates that CI was not estimable due to insufficient number of participants with events at study closure.

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms

Population: mITT population included all randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score	45 Participants	48 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=63 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=63 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Number of Participants With Best Response by Organ System Skin	20 Participants	28 Participants	1 Participants	—
Number of Participants With Best Response by Organ System Eyes	24 Participants	26 Participants	—	1 Participants
Number of Participants With Best Response by Organ System Mouth	23 Participants	31 Participants	1 Participants	1 Participants
Number of Participants With Best Response by Organ System Esophagus	13 Participants	7 Participants	—	—
Number of Participants With Best Response by Organ System Upper GI	9 Participants	4 Participants	—	—
Number of Participants With Best Response by Organ System Lower GI	5 Participants	6 Participants	—	—
Number of Participants With Best Response by Organ System Liver	2 Participants	1 Participants	—	—
Number of Participants With Best Response by Organ System Lungs	9 Participants	6 Participants	0 Participants	—
Number of Participants With Best Response by Organ System Joints and Fascia	42 Participants	39 Participants	—	—

SECONDARY outcome

Population: mITT population included all randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Percentage of Participants With Best Response of PR and CR PR	68.8 Percentage of participants	73.3 Percentage of participants	50.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Best Response of PR and CR CR	5.2 Percentage of participants	2.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=73 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=73 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction	-50.00 Percent change Interval -100.0 to 0.0	-66.67 Percent change Interval -100.0 to 900.0	-50.00 Percent change Interval -100.0 to 0.0	-60.00 Percent change Interval -60.0 to -60.0

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms

Population: 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.

Calcineurin inhibitors include systemic tacrolimus and cyclosporine. Percentage of participants with reduction and discontinuation of calcineurin inhibitor dose is presented.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=32 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=26 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=1 Participants 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).	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).
Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose Reduction of Calcineurin Inhibitor Dose	46.9 Percentage of participants	57.7 Percentage of participants	100.0 Percentage of participants	—
Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose Discontinuation of Calcineurin Inhibitor Dose	21.9 Percentage of participants	34.6 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: 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)

Population: mITT population included all randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Failure-Free Survival (FFS)	16.3 Months Interval 10.15 to 26.48	17.2 Months Interval 11.27 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.	NA Months NA indicates that median and CI was not estimable due to insufficient number of participants with events at study closure.	6.8 Months NA indicates that CI was not estimable due to insufficient number of participants with events at study closure.

SECONDARY outcome

Timeframe: 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)

Population: mITT population included all randomized participants who received at least one dose of study drug.

OS was defined as time from first dose of belumosudil to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Overall Survival (OS)	NA Months NA indicates that median and 95% CI was not estimable due to insufficient number of participants with events at study closure.	NA Months NA indicates that median and 95% CI was not estimable due to insufficient number of participants with events at study closure.	NA Months NA indicates that median and 95% CI was not estimable due to insufficient number of participants with events at study closure.	NA Months NA indicates that median and 95% CI was not estimable due to insufficient number of participants with events at study closure.

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment Baseline global severity rating score= 6-7: Best response	15 Participants	28 Participants	1 Participants	—
Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment Baseline global severity rating score >7: Best response	11 Participants	9 Participants	—	—
Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment Baseline global severity rating score < 6: Best response	9 Participants	8 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=52 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=48 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Change From Baseline in Patient Self-Reported Symptom Activity Based on cGVHD Activity Assessment	-0.9 Score on a scale Standard Deviation 2.4	-1.5 Score on a scale Standard Deviation 2.4	0.0 Score on a scale Standard Deviation 0.0	-1.0 Score on a scale Standard Deviation NA NA indicates that standard deviation could not be determined when only 1 participant was analyzed.

SECONDARY outcome

Timeframe: 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

Population: PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=5 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=5 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Maximum Concentration Observed (Cmax) of Belumosudil Cycle 4	—	—	NA Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA As pre-specified in protocol, Cmax was only calculated for participants with full PK samples. Thus, Cmax was not calculated for adolescent participants who only had sparse PK samples.	NA Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA As pre-specified in protocol, Cmax was only calculated for participants with full PK samples. Thus, Cmax was not calculated for adolescent participants who only had sparse PK samples.
Maximum Concentration Observed (Cmax) of Belumosudil Cycle 1	1350 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 127	870 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 177	—	—
Maximum Concentration Observed (Cmax) of Belumosudil Cycle 2	1780 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 154	2050 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 99.9	NA Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA As pre-specified in protocol, Cmax was only calculated for participants with full PK samples. Thus, Cmax was not calculated for adolescent participants who only had sparse PK samples.	NA Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA As pre-specified in protocol, Cmax was only calculated for participants with full PK samples. Thus, Cmax was not calculated for adolescent participants who only had sparse PK samples.

SECONDARY outcome

Timeframe: 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

Population: PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=5 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=5 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil Cycle 1	2.90 Hours Interval 1.1 to 5.95	4.00 Hours Interval 1.18 to 7.75	—	—
Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil Cycle 2	1.98 Hours Interval 1.88 to 2.07	1.26 Hours Interval 1.0 to 4.03	NA Hours As pre-specified in protocol, Tmax was only calculated for participants with full PK samples. Thus, Tmax was not calculated for adolescent participants who only had sparse PK samples.	NA Hours As pre-specified in protocol, Tmax was only calculated for participants with full PK samples. Thus, Tmax was not calculated for adolescent participants who only had sparse PK samples.
Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil Cycle 4	—	—	NA Hours As pre-specified in protocol, Tmax was only calculated for participants with full PK samples. Thus, Tmax was not calculated for adolescent participants who only had sparse PK samples.	NA Hours As pre-specified in protocol, Tmax was only calculated for participants with full PK samples. Thus, Tmax was not calculated for adolescent participants who only had sparse PK samples.

SECONDARY outcome

Timeframe: 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

Population: PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=5 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=5 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil Cycle 1	4430 Hours*ng/mL Geometric Coefficient of Variation 153	2380 Hours*ng/mL Geometric Coefficient of Variation 204	—	—
Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil Cycle 2	6860 Hours*ng/mL Geometric Coefficient of Variation 123	6520 Hours*ng/mL Geometric Coefficient of Variation 108	NA Hours*ng/mL Geometric Coefficient of Variation NA As pre-specified in protocol, AUC0-6 was only calculated for participants with full PK samples. Thus, AUC0-6 was not calculated for adolescent participants who only had sparse PK samples.	NA Hours*ng/mL Geometric Coefficient of Variation NA As pre-specified in protocol, AUC0-6 was only calculated for participants with full PK samples. Thus, AUC0-6 was not calculated for adolescent participants who only had sparse PK samples.
Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil Cycle 4	—	—	NA Hours*ng/mL Geometric Coefficient of Variation NA As pre-specified in protocol, AUC0-6 was only calculated for participants with full PK samples. Thus, AUC0-6 was not calculated for adolescent participants who only had sparse PK samples.	NA Hours*ng/mL Geometric Coefficient of Variation NA As pre-specified in protocol, AUC0-6 was only calculated for participants with full PK samples. Thus, AUC0-6 was not calculated for adolescent participants who only had sparse PK samples.

SECONDARY outcome

Timeframe: 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)

Population: Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment.

TTR was measured as the time from first treatment to the time of first documentation of response.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=57 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=57 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=1 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Time to Response (TTR)	4.43 Weeks Interval 3.7 to 80.1	4.43 Weeks Interval 3.7 to 40.1	7.57 Weeks Interval 7.5 to 7.6	4.14 Weeks Interval 4.1 to 4.2

SECONDARY outcome

Timeframe: 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)

Population: mITT population included all randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Adult Arm A: Belumosudil 200 mg QD n=77 Participants 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).	Adult Arm B: Belumosudil 200 mg BID n=75 Participants 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).	Adolescent Arm A: Belumosudil 200 mg QD n=2 Participants 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).	Adolescent Arm B: Belumosudil 200 mg BID n=1 Participants 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).
Time to Next Treatment (TTNT)	24.2 Months Interval 13.37 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.	NA Months Interval 14.55 to NA indicates that median and upper limit of CI was not estimable due to insufficient number of participants with events at study closure.	NA Months NA indicates that median and CI was not estimable due to insufficient number of participants with events at study closure.	6.8 Months NA indicates that CI was not estimable due to insufficient number of participants with events at study closure.

Adverse Events

Adult Arm A: Belumosudil 200 mg QD

Serious events: 36 serious events

Other events: 73 other events

Deaths: 14 deaths

Adult Arm B: Belumosudil 200 mg BID

Serious events: 30 serious events

Other events: 73 other events

Deaths: 14 deaths

Adolescent Arm A: Belumosudil 200 mg QD

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Adolescent Arm B: Belumosudil 200 mg BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610 ext 6#

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER