Trial · NCT06438614
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 | Number of Participants with Serious and Non-Serious Adverse Events | 14 months after ICF signature | The safety and tolerability of the treatment will be determined by means of type, incidence, severity, timing, seriousness, and relatedness of reported AEs, physical examinations, and laboratory tests. Toxicity will be graded and tabulated by the NCI CTCA E v 5 .0 |
| Primary | Best Overall Response (at the end of HITS treatment) | From first day of treatment with HITS until completion of HITS (39 days). | Best Overall Response is defined as the best response recorded from the start of the study treatment |
| Primary | Best Overall Response of Complete Response (CR) (at the end of HITS treatment) | From first day of treatment with HITS until completion of HITS(39 days). | The number and proportion of patients with CR as Best Overall Response at the end of HITS treatment |
| Primary | Objective Response Rate (at the end of HITS treatment) | From first day of treatment with HITS until completion of HITS (39 days). | Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response). |
| Primary | Clinical Benefit Rate (at the end of HITS treatment) | From first day of treatment with HITS until completion of HITS (39 days). | Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w |
| Primary | Best Overall Response (at the end of NICE treatment) | From first day of treatment with NICE until completion of NICE (39 days). | Best Overall Response is defined as the best response recorded from the start of the study treatment |
| Primary | Best Overall Response of Complete Response (CR) (at the end of NICE treatment) | From first day of treatment with NICE until completion of NICE (39 days). | The number and proportion of patients with CR as Best Overall Response at the end of NICE treatment |
| Primary | Objective Response Rate (at the end of NICE treatment) | From first day of treatment with NICE until completion of NICE (39 days). | Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response). |
| Primary | Clinical Benefit Rate (at the end of NICE treatment) | From first day of treatment with NICE until completion of NICE (39 days). | Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w |
| Secondary | To evaluate serum cytokines in patients receiving NICE | From first day of treatment with NICE, until day 11 post administration. | |
| Secondary | To measure MRD after HITS | From first day of treatment with HITS until completion of HITS (39 days). | Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017) |
| Secondary | To measure MRD after NICE | From first day of treatment with NICE until completion of NICE (39 days). | Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017) |
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/NCT06438614/registered