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NCT04375228 · ClinicalTrials.gov registry record · Phase 2
Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)
A Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events, sponsored by Columbia University.
- Active
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT04375228: Active Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events, sponsored by Columbia University.
NCT04375228 is a Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 8 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375228, a Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to examine how effective rituximab or tocilizumab are in treating side effects for people who are receiving immunotherapy treatment requiring prolonged steroid use. Immune-related side effects are caused by the activation of the immune system. Because rituximab and tocilizumab have been shown to effectively in treating other diseased that involve immune system activation, this study seeks to evaluate how effective they will be in treating immune-related side effects in people receiving immunotherapy treatment for cancer.
Primary Outcome
The percentage of participants able to discontinue steroid treatment within 4 weeks after the last dose of Rituximab.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Tocilizumab
Study Locations (3)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center - New York
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-09-25 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT04375228 still lists
NCT04375228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT04375228 reports a single indexed study location in New York, Maryland.
Frequently Asked Questions
What is clinical trial NCT04375228 about?
NCT04375228 is a clinical study titled "Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)". The purpose of this study is to examine how effective rituximab or tocilizumab are in treating side effects for people who are receiving immunotherapy treatment requiring prolonged steroid use. Immune-related side effects are caused by the activation of the immune system. Because rituximab and toci...
What is the current status of trial NCT04375228?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-09-25. Estimated completion is 2026-12.
What conditions does trial NCT04375228 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Immune Related Adverse Events.
What interventions are being tested in trial NCT04375228?
The interventions under investigation include: Rituximab (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT04375228?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375228 being conducted?
This trial has 3 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04375228's enrollment target sits among peer trials
8 189th of 189 the lowest of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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