Trial · NCT06143891
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | Until the end of the study (up to 2.5 years since first patient in). | From the date of randomization to the date of any predefined event, whichever occurs first |
| Secondary | Modified Lee Symptom Scale (mLSS) | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants who achieve a clinically relevant reduction in mLSS of at least 6 points from baseline (Only in participants at least 18 years of age) |
| Secondary | Durable overall response rate | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants who achieve an overall response (PR or CR) as per 2014 NIH consensus response criteria by 48 weeks and maintained the response for a duration of at least 6 months |
| Secondary | Rate of corticosteroid withdrawal | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants who successfully discontinue all systemic corticosteroids for cGVHD for at least 30 days before the occurrence of cGVHD progression, or start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or unacceptable toxicity |
| Secondary | Overall response rate (ORR) | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD |
| Secondary | ORR by 24 weeks | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria by 24 weeks (Cycle 7 Day 1) before the start of new systemic treatment for cGVHD |
| Secondary | Duration of response (DOR) | Until the end of the study (up to 2.5 years since first patient in). | Time from the date of the first response to the date of cGVHD progression, 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 | Dose reduction in corticosteroid | Until the end of the study (up to 2.5 years since first patient in). | Proportion of participants with a reduction in daily corticosteroid dose |
| Secondary | Failure Free Survival (FFS) | Until the end of the study (up to 2.5 years since first patient in). | Failure Free Survival (FFS) is defined as the time from the date of randomization to the date of start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first. |
| Secondary | Change in patient reported outcome (PRO) | Until the end of the study (up to 2.5 years since first patient in). | Change from baseline in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) (Only in participants at least 18 years of age) and the European Quality of Life Group Questionnaire with 5 Dimensions and 5 Levels (EQ5D5L) |
| Secondary | Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Until the end of the study (up to 2.5 years since first patient in). | |
| Secondary | Overall survival | Until the end of the study (up to 2.5 years since first patient in). | The time from the date of randomization to the date of death due to any cause |
| Secondary | Time to response (TTR) | Until the end of study (up to 2.5 years since first patient in) | Time to Response is defined as the time from randomization to the date the patient has first response (CR or PR). |
| Secondary | Response by organ | Until the end of study (up to 2.5 years since first patient in) | Proportion of participants who achieve CR or PR as per NIH consensus response criteria (2014) at any time point in each involved organ and before the start of a new systemic therapy for cGVHD. |
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/NCT06143891/registered