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Rituximab or Tocilizumab for Immune-Related Side Effects

Phase 2
Recruiting
Led By Brian Henick, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that develop irAEs secondary to treatment with immune checkpoint inhibitors. Diagnostic evaluation of irAEs must include agreement between medical oncologist and disease-specific subspecialist (e.g. rheumatologist, dermatologist) on therapeutic rationale for either rituximab or tocilizumab-based therapy or if evidence-based indications exist as summarized below: Dermatologic (bullous pemphigoid, pemphigus vulgaris) - Rituximab. Neurologic (autoimmune encephalitis) - Rituximab. Hematologic (immune thrombocytopenia, autoimmune hemolytic anemia) -Rituximab. Rheumatologic (rheumatoid arthritis, psoriatic arthritis) -Rituximab/Tocilizumab. Renal (autoimmune nephritis) - Rituximab. Pulmonary (pneumonitis) - Tocilizumab. Cardiac (autoimmune myocarditis) - Tocilizumab
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial will test how well two drugs work to treat side effects in people getting immunotherapy for cancer.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors who have immune-related side effects from immunotherapy and can't reduce their steroid use below a certain level. They must be able to consent, not be pregnant or breastfeeding, agree to contraception, have adequate organ function, and not have any conditions that would interfere with the study.Check my eligibility
What is being tested?
The study tests Rituximab or Tocilizumab's effectiveness in treating immune-related adverse events in cancer patients on prolonged steroids due to immunotherapy. It aims to see if these drugs can manage side effects caused by an activated immune system.See study design
What are the potential side effects?
Rituximab may cause infusion reactions, infections, body aches, tiredness and heart problems. Tocilizumab could lead to upper respiratory tract infections, headache, high blood pressure and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced solid tumors and have experienced certain immune-related side effects from immune checkpoint inhibitors. To determine the appropriate treatment, your medical oncologist and a specialist (such as a rheumatologist or dermatologist) will evaluate your condition. They may recommend therapy with rituximab or tocilizumab, depending on the specific side effect you have. For example, if you have a skin condition, rituximab may be used, while tocilizumab may be used for lung or heart-related issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants to Discontinue Steroid Treatment After Rituximab
Percentage of Participants to Discontinue Steroid Treatment After Tocilizumab
Secondary outcome measures
Number of Participants with a Change in CTCAE (v5.0) Grade
The Number Steroid-Dependent Immune-Related Adverse Events

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

2Treatment groups
Experimental Treatment
Group I: TocilizumabExperimental Treatment1 Intervention
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
Group II: RituximabExperimental Treatment1 Intervention
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,472,997 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,650 Total Patients Enrolled
Brian Henick, MDPrincipal InvestigatorAssistant Professor of Medicine in the Division of Hematology and Oncology
4 Previous Clinical Trials
435 Total Patients Enrolled

Media Library

Rituximab Clinical Trial Eligibility Overview. Trial Name: NCT04375228 — Phase 2
Adverse Events Research Study Groups: Tocilizumab, Rituximab
Adverse Events Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT04375228 — Phase 2
Rituximab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375228 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for this research initiative?

"As per the information posted on clinicaltrials.gov, this medical study is actively recruiting patients and was last updated on April 7th 2022. The trial first began accepting applications from participants on September 25th 2020."

Answered by AI

Has the Food and Drug Administration granted approval for Rituximab?

"Our team has conservatively graded Rituximab's safety as a 2 since it is currently being studied in Phase 2 trials, with data pointing to its security but not yet proving its effectiveness."

Answered by AI

What is the aggregate amount of people participating in this medical trial?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, inaugurated on September 25th 2020, is actively seeking participants. 30 individuals are being sought from 3 different medical centres."

Answered by AI

Have scientists previously conducted research using Rituximab?

"Rituximab's research first began at National Institutes of Health Clinical Center in 1993, and 1020 have been concluded since then. Of the current 470 clinical trials taking place worldwide, a notable amount are conducted out of Baltimore, Maryland."

Answered by AI

For what purposes is Rituximab frequently utilized?

"Rituximab is traditionally prescribed to combat diffuse large b-cell lymphoma (dlbcl). It has also been found effective for the treatment of systemic juvenile idiopathic arthritis (sjia), and other varieties of B-Cell Lymphomas, such as Polyangiitis."

Answered by AI
~7 spots leftby Mar 2025