Trial · NCT03275402
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
NCT03275402, Phase 2, Phase 3, Terminated, Y-mAbs Therapeutics; results first posted 2024-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases. Trials, record NCT03275402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03275402
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
- NCT number
- NCT03275402
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- Y-mAbs Therapeutics
- Conditions
- Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
- Interventions
- 131I-omburtamab
- First posted
- 2017-09-07
- Last updated
- 2024-02-13
- Results first posted
- 2024-02-13
- Limitations and caveats
- The trial was terminated early due to a business strategy decision.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Rate | 3 years | Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Rate | 3 years | Full analysis set | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Rate | 131I-omburtamab | 0.65 | 95% Confidence Interval 0.49 to 0.78 | Proportion of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 131I-omburtamab | 52 | |
| Overall Study | COMPLETED | 131I-omburtamab | 13 | |
| Overall Study | NOT COMPLETED | 131I-omburtamab | 39 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 131I-omburtamab | 15 | 52 | 22 |
| other | Tachycardia | Cardiac disorders | 131I-omburtamab | 4 | 52 | 10 |
| other | Hypothyroidism | Endocrine disorders | 131I-omburtamab | 4 | 52 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | 131I-omburtamab | 4 | 52 | 4 |
| other | Constipation | Gastrointestinal disorders | 131I-omburtamab | 3 | 52 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | 131I-omburtamab | 3 | 52 | 3 |
| other | Nausea | Gastrointestinal disorders | 131I-omburtamab | 19 | 52 | 21 |
| other | Vomiting | Gastrointestinal disorders | 131I-omburtamab | 18 | 52 | 25 |
| other | Fatigue | General disorders | 131I-omburtamab | 4 | 52 | 4 |
| other | Pain | General disorders | 131I-omburtamab | 6 | 52 | 20 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 131I-omburtamab | 17 | 52 |
| Total, other adverse events | 131I-omburtamab | 49 | 52 |
| Total, serious adverse events | 131I-omburtamab | 20 | 52 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03275402
GET https://conductscience.org/api/trials/v1/NCT03275402/events?page=2