Trial · NCT05567406
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment emergent adverse events and serious adverse events | Up to approximately 48 months | Safety will be assessed by monitoring adverse events, physical Examinations, clinical laboratory evaluations, vital sign measurements, and ECG parameters. |
| Primary | Number of participants with clinically significant laboratory abnormalities | Up to approximately 12 months | |
| Primary | Change from baseline in systolic and diastolic blood pressure | Baseline; up to approximately 12 months | |
| Primary | Change from baseline in heart rate | Baseline; up to approximately 12 months | |
| Primary | Change from baseline in corrected QT interval using Fridericia's formula (QTc[F]) | Baseline; up to approximately 12 months | |
| Primary | Overall Response Rate (ORR) | Up to approximately 12 months | The ORR is defined as the proportion of participants meeting the overall response criteria assessment of Complete Response (CR) or Partial Response (PR) as defined by the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD at any post-baseline response assessment. |
| Secondary | Duration of Response (DOR) | Up to approximately 12 months | Assessments of DOR includes * The time from first response to progression, death, or new systemic therapy for cGVHD * Time from initial response to start of additional systemic cGVHD therapy or death |
| Secondary | Change from baseline in the Lee Symptom Scale Score: Number of participants with a ≥ 7-point reduction | Baseline; up to approximately 12 months | Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment. |
| Secondary | Change from baseline in the Lee Symptom Scale Score: Number of participants with a ≥ 7-point reduction on 2 consecutive assessments | Baseline; up to approximately 12 months | Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment. |
| Secondary | Change from baseline in the Lee Symptom Scale Score: Duration of a ≥ 7 point reduction | Baseline; up to approximately 12 months | Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment. |
| Secondary | Response rate by organ system | Up to approximately 12 months | The response rate for the nine individual organs (skin, eyes, mouth, esophagus, upper GI, lower GI, liver, lungs, and joints and fascia) will be assessed by the clinician. |
| Secondary | Time to Response (TTR) | Up to approximately 12 months | TTR defined as the time from the first dose of belumosudil to the first documented cGVHD response. |
| Secondary | Time to Next Treatment (TTNT) | Up to approximately 12 months | TTNT defined as the time from the first dose of belumosudil to the start of additional systemic cGVHD therapy. |
| Secondary | Number of participants who have a best response of PR and CR | Up to approximately 12 months | CR is defined as resolution of all manifestations of cGVHD in each organ or site. PR is defined as Improvement in at least 1 organ or site without progression in any other organ or site. |
| Secondary | Change from baseline in corticosteroid dose | Baseline; up to approximately 12 months | The prednisone equivalent dose of corticosteroids (mg/kg/day) during the study will be analyzed. The change in systemic corticosteroid dose over time will be determined. |
| Secondary | Change from baseline in calcineurin inhibitor dose | Baseline; up to approximately 12 months | The change in calcineurin inhibitor dose over time will be determined. |
| Secondary | Failure-free survival (FFS) | Up to approximately 12 months | FFS defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy. Median FFS (from first dose of belumosudil) will be analyzed. |
| Secondary | Overall survival (OS) | Up to approximately 12 months | OS defined as time from first dose of belumosudil to the date of death due to any cause. |
| Secondary | Change from baseline in cGVHD global severity rating using the Clinician-Reported Global cGVHD Activity Assessment | Baseline; up to approximately 12 months | Patient-reported outcome |
| Secondary | Change from baseline in symptom activity as based on cGVHD Activity Assessment Patient Self-Report | Baseline; up to approximately 12 months | Patient-reported outcome |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05567406/registered