Trial · NCT06438614
A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
NCT06438614, Phase 2, Completed, Fundació Sant Joan de Déu
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma. Trials, record NCT06438614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06438614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
- NCT number
- NCT06438614
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Fundació Sant Joan de Déu
- Conditions
- Refractory Neuroblastoma, Soft Tissue Cancer
- Interventions
- HITS, Naxitamab + GM-CSF cycles, NICE
- First posted
- 2024-06-03
- Last updated
- 2024-08-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT06438614
GET https://conductscience.org/api/trials/v1/NCT06438614/registered