Trial · NCT04930562
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
NCT04930562, Phase 2, Completed, BioNova Pharmaceuticals (Shanghai) LTD.; results first posted 2023-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD). Trials, record NCT04930562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04930562
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
- NCT number
- NCT04930562
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- BioNova Pharmaceuticals (Shanghai) LTD.
- Conditions
- GVHD, Chronic
- Interventions
- BN101
- First posted
- 2021-06-18
- Last updated
- 2024-01-17
- Results first posted
- 2023-11-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 12 Months | OR was defined as the percentage of participants with complete response (CR) or partial response (PR). The OR determination of chronic graft versus host disease (cGVHD) was based on cGVHD response assessment performed by clinicians as per the 2014 National Institutes of Health (NIH) Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; and cGVHD progression was defined as the clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. |
| Secondary | Duration of Response (DOR) | 12 Months | The DOR was defined as the time (in weeks) from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to LR). LOR included the response status of unchanged (LOR-U), mixed (LOR-M), or progression (LOR-P). Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site; PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; LOR-M was defined as CR or PR in at least one organ accompanied by progression in another organ, LOR-U was defined as outcomes that did not meet the criteria for CR, PR, progression or mixed response, LOR-P was defined as progression in at least one organ or site without a response in any other organ or site. Kaplan-Meier was used for the analysis. |
| Secondary | Time-to-Response (TTR) | 12 months | Time-to-response was measured as the time (in weeks) from first dose of study drug to the time of first documentation of response. Response was defined as the participants achieving a PR or CR at any post-baseline response assessment. Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site and PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site |
| Secondary | Number of Participants With Best Response in Each Individual Organ | 12 months | Best response was defined as the percentage of participants with CR or PR. Response was assessed per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site; PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site. Organ response assessment was performed on 9 individual organs: skin, eyes, mouth, esophagus, upper gastrointestinal (GI), lower GI, liver, lungs, and joints and fascia and is reported in this outcome measure. |
| Secondary | Number of Participants With Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points | Baseline and 12 months | Lee cGVHD symptom scale, a patient-reported symptom scale used to measure symptom burden and has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely, with lower values representing better outcome. Score for each subscale was normalized to a score ranged from 0 to 100, where higher score=worse symptoms. An overall Lee cGvHD score was calculated as average of these 7 subscales and it ranged from 0 to 100, where a higher score = worse symptoms. EOT visit was performed within 3 days after the participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. |
| Secondary | Failure-free Survival (FFS) | 12 months | Failure-free survival was defined as the time (in months) from first dose of study drug to either the start of another new systemic treatment for cGVHD, relapse of the underlying disease or death. If no such events happened, FFS was censored by last response assessment or long term follow up assessment, whichever was the latest and available. Kaplan-Meier survival method was used for the analysis. |
| Secondary | Time to Next Therapy (TTNT) | 12months | The TTNT was defined as the time (in months) from first treatment to the time of new systemic cGVHD treatment. TTNT was censored by last response assessment or long term follow up assessment, whichever was earlier. Kaplan-Meier survival method was used for the analysis. |
| Secondary | Overall Survival (OS) | 12months | Overall survival was defined as the time (in months) from first dose of study drug to the death due to any reason. If there was no death, OS was censored by last visit, last long-term follow-up, or study cut-off date, whichever occurred first. Kaplan-Meier survival method was used for the analysis. |
| Secondary | Change From Baseline in Corticosteroids Dose | 12months | Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 7 days after the participant's last dose of study drug. |
| Secondary | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage. | 12months | Calcineurin inhibitors included systemic tacrolimus and cyclosporine. Number of participants who took CNI at Baseline and had reduction and discontinuation in CNI use as compared to Baseline during the study are reported in this outcome measure. EOT visit was performed within 7 days after the participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 12 Months | Analysis was performed on mITT population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | 12 Months | Analysis was performed on responder population which included participants who received at least 1 dose of study medication and achieved a PR or CR response at any post-baseline response assessment. | weeks | MEDIAN |
| SECONDARY | Time-to-Response (TTR) | 12 months | Analysis was performed on responder population. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Best Response in Each Individual Organ | 12 months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. The number of participants analyzed is the number of patients with abnormalities in each organ. | participants | NUMBER |
| SECONDARY | Number of Participants With Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points | Baseline and 12 months | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Failure-free Survival (FFS) | 12 months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first | months | MEDIAN |
| SECONDARY | Time to Next Therapy (TTNT) | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | months | MEDIAN |
| SECONDARY | Change From Baseline in Corticosteroids Dose | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | milligrams per kilogram per day | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage. | 12months | Number of participants who took CNI at Baseline. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | 200mg qd | 73.3 | 95% Confidence Interval 54.1 to 87.7 | percentage of participants | |
| Duration of Response (DOR) | 200mg qd | 20.2 | 95% Confidence Interval 9.71 to NA | weeks | |
| Time-to-Response (TTR) | 200mg qd | 4.29 | Full Range 3.9 to 48.1 | weeks | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Skin | 8 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Eyes | 6 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Mouth | 12 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Esophagus | 3 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Upper GI tract | 2 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Liver | 6 | participants | |
| Number of Participants With Best Response in Each Individual Organ | 200mg qd | Lungs | 2 | participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 200mg qd | 30 | |
| Overall Study | COMPLETED | 200mg qd | 30 | |
| Overall Study | NOT COMPLETED | 200mg qd | 0 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | 200mg qd | 12 | 30 | |
| other | Sinus tachycardia | Cardiac disorders | 200mg qd | 11 | 30 | |
| other | Pneumonia | Infections and infestations | 200mg qd | 7 | 30 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | 200mg qd | 5 | 30 | |
| other | Liver injury | Hepatobiliary disorders | 200mg qd | 5 | 30 | |
| other | Hypertension | Blood and lymphatic system disorders | 200mg qd | 3 | 30 | |
| other | Alanine aminotransferase increased | Investigations | 200mg qd | 3 | 30 | |
| other | Blood creatinine increased | Investigations | 200mg qd | 3 | 30 | |
| other | Blood glucose increased | Investigations | 200mg qd | 3 | 30 | |
| other | Nausea | Gastrointestinal disorders | 200mg qd | 3 | 30 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 200mg qd | 5 | 30 |
| Total, other adverse events | 200mg qd | 29 | 30 |
| Total, serious adverse events | 200mg qd | 11 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38532458 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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