Trial · NCT07537400
Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5
NCT07537400, Phase 2, Recruiting, Shaare Zedek Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5. Trials, record NCT07537400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07537400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5
- NCT number
- NCT07537400
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Shaare Zedek Medical Center
- Conditions
- High-Risk Neuroblastoma
- Interventions
- Naxitamab
- First posted
- 2026-04-17
- Last updated
- 2026-09-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma | Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months) | This measure will be assessed by evaluating treatment side effects. |
| Primary | Assess end-of-induction (EOI) response rates following concurrent Naxitamab and induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma. | Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months) | This measure will be assessed using the 1993 International Neuroblastoma Response Criteria (INRC) criteria. |
| Primary | Assess end-of-induction (EOI) response rates following additional cycles of Irinotecan-Temodar-Naxitamab-GM-CSF in patients with high risk neuroblastoma and less than partial response (PR) after induction with COG type chemotherapy and Naxitamab | Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months) | |
| Secondary | Determine event-free survival (EFS) in newly diagnosed high-risk neuroblastoma patients | From enrollment until completion of follow-up, 5 years from diagnosis | |
| Secondary | Metastatic complete response after cycle 2 and at end of induction. | Post 2nd course, and post 5th course of induction therapy (therapy lasts approximately 4 and a half months) | To be assessed using one of the following: MIBG - Metaiodobenzylguanidin; CT - Computed Tomography; MRI - Magnetic Resonance Imaging; PET-DOPA - Fluorine-18 Fluorodopa Positron Emission Tomography. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07537400
GET https://conductscience.org/api/trials/v1/NCT07537400/registered