Trial · NCT04710576
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD) | First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks) | The ORR was defined as the percentage of participants with objective response (complete response \[CR\] or partial response \[PR\]). CR was defined as resolution of all manifestations in each organ or site, and PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. |
| Secondary | ORR on Study as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD | Up to 2 years | |
| Secondary | Number of Participants With a Clinically Significant Improvement in Normalized Score on the Modified Lee Symptom Scale | Up to 2 years | |
| Secondary | Duration of Response | Up to 2 years | Duration of response is defined as the time from initial partial response or complete response until documented progression of cGVHD, start of new therapy, or death for any reason. |
| Secondary | Sustained Response Rate | Up to 2 years | Sustained response rate is defined as the number of participants with objective response lasting for at least 20 weeks (140 days) from the time of initial response. Responses will be assessed based on the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD. |
| Secondary | Organ-specific Response Rate | Up to 2 years | Organ-specific response is defined as the number of participants with objective response for the nine individual organs based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (skin, eyes, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lungs and joints and fascia). |
| Secondary | Joints and Fascia Response Rate Based on Refined NIH Response Algorithm for cGVHD | Up to 2 years | |
| Secondary | Percent Reductions in Average Daily Doses (or Equivalent) of Corticosteroid | Up to 2 years | |
| Secondary | Number of Participants Who Discontinue Corticosteroid Use | Up to 2 years | |
| Secondary | Percent Reductions in Average Daily Doses (or Equivalent) of Calcineurin Inhibitors (CNI) | Up to 2 years | |
| Secondary | Number of Participants Who Discontinue CNIs | Up to 2 years | |
| Secondary | Change From Baseline in Circulating Monocyte Number and Phenotype (CD14/16) | Baseline, up to 2 years | |
| Secondary | Number of Participants With Anti-Drug Antibody | Up to 2 years | |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Measurable Concentration (AUC0-t) | Approximately 12 months | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Up to 2 years | |
| Secondary | Change From Baseline in Bone Turnover Markers | Baseline, up to 2 years | |
| Secondary | Change From Baseline in Bone Density | Baseline, up to 2 years | |
| Secondary | Change From Baseline in Colony Stimulating Factor 1 (CSF-1) and Interleukin 34 (IL-34) Levels | Baseline, up to 2 years |
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.
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GET https://conductscience.org/api/trials/v1/NCT04710576/registered