Trial · NCT06616415
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma concentrations of belumosudil at specified time points | At Day 1 and Day 29(±3) | |
| Secondary | Overall response rate (ORR) | Up to 18 month | Overall response rate (ORR, including complete response \[CR\] and partial response \[PR\]), which will be assessed by the investigator according to the NIH Consensus Criteria (2014) at any time before the start of new systemic treatment for cGVHD. |
| Secondary | Duration of response (DoR) | Up to 18 month | Duration of response (DoR): time from the date of the first response to the date of cGVHD progression as defined by 2014 NIH consensus response criteria, start of new systemic treatment for cGVHD, or death, whichever occurs first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH consensus response criteria. |
| Secondary | System organ response rate | Up to 18 month | System organ response rate: proportion of participants who achieve an overall response (CR or PR) for each of the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD |
| Secondary | Number and proportion of participants with dose reduction in corticosteroid during the treatment period | Up to 18 month | |
| Secondary | Failure-free survival (FFS) | Up to 18 month | Failure-free survival (FFS): time from the date of the first administration of IMP to 1) the date of initiation of new systemic treatment for cGVHD, or 2) date of death, or 3) date of recurrent underlying disease, whichever occurs first |
| Secondary | Overall survival (OS) | Up to 18 month | Overall survival (OS): time from the date of the first administration of IMP to the date of death due to any cause |
| Secondary | Change in cGVHD severity based on physician-reported overall cGVHD activity | Up to 18 month | |
| Secondary | Change in symptom activity assessed based on patient-reported cGVHD activity | Up to 18 month | |
| Secondary | Modified Lee cGVHD Symptom Scale change | Up to 18 month | The scale contains 30 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Patients report how "bothered" they feel about each symptom using a five-point Likert scale from "not at all" (0) to "extremely" (4). A higher score indicating worse symptoms, reporting score will be normalizing to a 0 to 100 scale. |
| Secondary | Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period | Up to 18 month | |
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest (AESIs) | Up to 18 month |
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
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GET https://conductscience.org/api/trials/v1/NCT06616415/registered