Trial · NCT06538181
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose-limiting toxicities (DLTs) | Through completion of cycle 1 (estimated to be 28 days) | Dose-limiting toxicities (DLTs) are adverse events defined by the protocol that occur during the DLT observation period (Cycle 1) of the study, unless clearly attributable to underlying disease or another cause unrelated to the study. |
| Primary | Recommended phase II dose (RP2D) | Through completion of cycle 1 (each cycle is 28 days) for all treated participants | The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) during the first cycle. The recommended phase II dose (RP2D) will be less than or equal to the MTD. If the MTD is not reached, and in the opinion of the investigators, the toxicity profile is acceptable, Dose Level 1 will be the RP2D. |
| Secondary | Change in white blood cell count | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in absolute neutrophil count | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in absolute lymphocyte count | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in hemoglobin | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in platelets | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Number of participants with hematologic improvement as measured with neutrophils | Through completion of treatment (estimated to be 12 months) | Using IWG 2018 criteria |
| Secondary | Number of participants with hematologic improvement as measured with hemoglobin | Through completion of treatment (estimated to be 12 months) | Using IWG 2018 criteria |
| Secondary | Number of participants with hematologic improvement as measured with platelets | Through completion of treatment (estimated to be 12 months) | Using IWG 2018 criteria |
| Secondary | UBA1 variant allele frequency | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in C reactive protein (CRP) | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in ferritin | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in ESR | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Change in inflammatory and rheumatologic symptoms as measured by the VEXAS Disease Activity Index | Baseline, 1 month, 3 months, 6 months, and 12 months | |
| Secondary | Time to next treatment | Through completion of follow-up (estimated to be 24 months) |
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.
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GET https://conductscience.org/api/trials/v1/NCT06538181/registered