Trial · NCT04909515
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
NCT04909515, Phase 2, Withdrawn, Y-mAbs Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. Trials, record NCT04909515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04909515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
- NCT number
- NCT04909515
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Y-mAbs Therapeutics
- Conditions
- Neuroblastoma
- Interventions
- Naxitamab, GM-CSF, Isotretinoin
- First posted
- 2021-06-01
- Last updated
- 2022-09-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-year progression free survival (PFS) | 2 years | 2-year PFS defined as the proportion of patients alive and without progressive disease (PD) or relapse 2 years after enrollment |
| Secondary | Progression free survival | 128 weeks | Progression free survival (defined as time from enrollment until progressive disease/relapse or death, whichever comes first) |
| Secondary | 1-year progression free survival | 1 year | 1-year progression free survival defined as the proportion of patients alive and without progressive disease or relapse 1 year after enrollment |
| Secondary | 1-year and 2-year overall survival | 2 years | 1-year and 2-year overall survival defined as the proportion of patients alive 1 year and 2 years after enrollment, respectively |
| Secondary | 2-year event-free survival | 2 years | 2-year event-free survival, defined as the proportion of patients alive and without progressive disease, relapse, secondary malignancy or until last contact if no event occurred, 2 years after enrollment |
| Secondary | Proportion of positive to negative minimal residual disease (MRD) after 2 cycles | 6 weeks | Proportion of patients changing from minimal residual disease positive in bone marrow at enrollment (defined as patients assessed as minimal residual disease positive by RTqPCR of bone marrow at enrollment) to minimal residual disease negative at completion of Cycle 2 |
| Secondary | Proportion of patients with MD positive convert to MRD negative | 6 weeks | Proportion of patients with disease in bone marrow at enrollment (i.e., minimal disease according to INRC) and convert to minimal residual disease negative (assessed by RTqPCR) at completion of Cycle 2 |
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/NCT04909515
GET https://conductscience.org/api/trials/v1/NCT04909515/registered