Trial · NCT07437963
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose (Phase 1) | Up to the completion of phase 1 | Will be assessed by determining the recommended phase 2 dose of iberdomide administered in combination with dinutuximab, cyclophosphamide, topotecan, and granulocyte-macrophage colony-stimulating factor (GM-CSF) using the rolling six design. |
| Primary | Response rate (Phase 2) | Post-randomization through the end of cycle 12 (Cycle length = 28 days) | Responders are defined as patients who achieve a minor response (MR) or better, per the revised International Neuroblastoma Response Criteria (INRC), as their best overall response at any time post-randomization through the end of cycle 12. The response rate by the end of 12 cycles as determined by central review will be calculated, including placement of a 95% confidence interval. |
| Secondary | Response rate (Phase 1) | Up to 12 cycles (Cycle length = 28 days) | Responders are defined as patients who achieve a minor response (MR) or better, per the revised International Neuroblastoma Response Criteria (INRC), as their best overall response at any time through the end of cycle 12. The response rate by the end of 12 cycles as determined by the institution will be calculated, including placement of a 95% confidence interval. |
| Secondary | Progression-free survival (Phase 2) | Up to 1 year | Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up. 1-Year PFS is provided. |
| Secondary | Overall survival (Phase 2) | Up to 1 year | Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.1-Year OS is provided. |
| Secondary | Confirmed response rate (Phase 2) | Up to 12 cycles (Cycle length = 28 days) | A confirmed response is defined as a minor response (MR) or better that is confirmed by a second disease evaluation obtained at least 4 weeks after first documentation of MR or better. The confirmed response rate will be provided. |
| Secondary | Duration of response (Phase 2) | Up to 5 years | Duration of response will be calculated as the time from first achievement of response to disease progression or death in patients who achieve a minor response (MR) or better. Duration of response will be provided. |
| Other | Pharmacokinetic (PK) parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF | Cycle (C) 1 day (D) 1, C1D2, and C1D8, 9, or 10 (Phase 1 patients) and C1D8, C2D8, and C3D8 (Phase 2 patients) (Cycle length = 28 days) | PK parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF at steady state will be performed. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges and standard deviations. |
| Other | Pharmacodynamic (PD) parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF (Phase 1) | C1D1 and C1D2 (Cycle length = 28 days) | PD parameters of iberdomide in combination with dinutuximab, cyclophosphamide, topotecan, and GM-CSF at steady state will be performed. The PD parameters will be summarized with simple summary statistics, including means, medians, ranges and standard deviations. |
| Other | Immune profiling results (Phase 2) | C1D1, C1D15 or 22, C2D1, C3D1, and at progression (Cycle length = 28 days) | Immune profiling results will be summarized with descriptive statistics, including describing changes in markers over time. Markers will be correlated with response via a chi-square test. |
| Other | GD2 levels in tumor cells from bone marrow samples and response | After 6 cycles (Cycle length = 28 days) | Will correlate GD2 levels in tumor cells from bone marrow samples with response (responder versus non-responder) after 6 cycles using Fisher's exact test for categorical and the Wilcoxon rank-sum test for continuous factors. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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