Trial · NCT05106296
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 | Incidence of regimen-limiting toxicity (RLT) for Regimen A | First 90 days of treatment | To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A) |
| Primary | Objective Response Rate (ORR) for Regimen A | Up to 5 years | Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria |
| Primary | Incidence of regimen-limiting toxicity (RLT) for Regimen B | First 90 days of treatment | To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen B) |
| Primary | Objective Response Rate (ORR) for Regimen B | Up to 5 years | Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria |
| Secondary | Adverse events (AEs) | Up to 19 months | To assess frequency, severity, and recoverability of AEs for the treatment regimen |
| Secondary | Frequency of cycle delays for toxicity | Up to 18 months | To assess whether the immunotherapy contributes to delays in starting subsequent cycles of the chemotherapy drugs |
| Secondary | Frequency of dose-reductions of the chemotherapy regimen | Up to 18 months | To assess whether the immunotherapy contributes to reductions in the doses of the chemotherapy drugs |
| Secondary | Complete Response Rate (CRR) | Up to 5 years | Defined as the proportion of patients with a best objective response of CR using iRANO criteria |
| Secondary | Partial Response Rate (PRR) | Up to 5 years | Defined as the proportion of patients with a best objective response of PR using iRANO criteria |
| Secondary | Modified Objective Response Rate (mORR) | Up to 5 years | Defined as the proportion of patients with best objective response of complete response (CR), partial response (PR), or stable disease (SD, on at least 2 sequential study-timed MRIs) using iRANO criteria |
| Secondary | iRANO-PFS | Up to 5 years | Time of Progression-Free Survival (PFS), defined as time from study entry to progression using iRANO criteria |
| Secondary | Overall Survival (OS) | Up to 5 years | Time from study entry to death |
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/NCT05106296/registered