Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)
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|ClinicalTrials.gov Identifier: NCT04375228|
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : April 11, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Immune-related Adverse Events Advanced Solid Tumor||Drug: Rituximab Drug: Tocilizumab||Phase 2|
The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions.
Participants in this study have developed an immune-related adverse event while on immunotherapy and require a long course of steroids to manage this side effect. Steroids can cause many side effects with prolonged use including problems with sleep, weight gain, diabetes, muscle loss, high blood pressure, high cholesterol, bone loss, and mood disturbances. Drugs such as rituximab and tocilizumab have been shown to be effective in other diseases involving immune system activation. This study is evaluating the effectiveness of these drugs in patients who have immune-related side effects by their ability to help patients discontinue steroids.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be assigned either rituximab or tocilizumab based on clinical rationale and consensus recommendation by investigators.|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-Dependent Immune-Related Adverse Events Due to Immune Checkpoint Blockade|
|Actual Study Start Date :||September 25, 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||February 2024|
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
375mg/m^2 IV weekly for 4 doses
Other Name: RITUXAN
Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.
4mg/kg IV once a month for up to 2 doses
Other Name: ACTEMRA
- Percentage of Participants to Discontinue Steroid Treatment After Rituximab [ Time Frame: Up to 8 weeks ]The percentage of participants able to discontinue steroid treatment within 4 weeks after the last dose of Rituximab.
- Percentage of Participants to Discontinue Steroid Treatment After Tocilizumab [ Time Frame: Up to 12 weeks ]The percentage of participants able to discontinue steroid treatment within 4 weeks after the last dose of Tocilizumab.
- Number of Participants with a Change in CTCAE (v5.0) Grade [ Time Frame: Up to 24 weeks ]The number of participants with a change in CTCAE (v5.0) grade in participants who develop steroid-dependent immune related adverse events.
- The Number Steroid-Dependent Immune-Related Adverse Events [ Time Frame: Up to 24 weeks ]To evaluate the safety of rituximab and tocilizumab defined as the number of steroid-dependent immune-related adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375228
|Contact: Research Nurse Navigator||(212) 342 email@example.com|
|United States, Maryland|
|Johns Hopkins||Not yet recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Jarushka Naidoo, MBBCh 410-550-2646 firstname.lastname@example.org|
|Principal Investigator: Jarushka Naidoo, MBBCh|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10022|
|Contact: Mario Lacoutre, MD 646-888-6014 LacoutuM@mskcc.org|
|Principal Investigator: Mario Lacoutre, MD|
|Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 email@example.com|
|Principal Investigator: Brian Henick, MD|
|Sub-Investigator: Naiyer Rizvi, MD|
|Sub-Investigator: Joan M Bathon, MD|
|Sub-Investigator: Robert Winchester, MD|
|Sub-Investigator: Adam Mor, MD, PhD|
|Sub-Investigator: Catherine Shu, MD|
|Sub-Investigator: Imo Akpan, MD|
|Sub-Investigator: Sean Fedyna, MD|
|Sub-Investigator: Stephanie Gallitano, MD|
|Sub-Investigator: Jayant Raikhelkar, MD|
|Sub-Investigator: Mary Welch, MD|
|Principal Investigator:||Brian Henick, MD||Assistant Professor of Medicine in the Division of Hematology and Oncology|