Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy
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|ClinicalTrials.gov Identifier: NCT04975555|
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : November 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cytokine Release Syndrome ICANS Lymphoma, Non-Hodgkin Multiple Myeloma Acute Lymphoblastic Leukemia||Drug: Siltuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to Chimeric Antigen Receptor T-Cell Therapy (CAR-T) in Hematological Malignancies|
|Actual Study Start Date :||November 15, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
Patients who experience CRS/ICANS will receive this treatment
Siltuximab is administered at the dose of 11mg/kg via intravenous infusion over 1 hour. If no resolution of CRS is achieved then a repeat dose of siltuximab at the dose of 11mg/kg via intravenous infusion over 1 hour will be given.
- Participants with a complete response for cytokine release syndrome (CRS) [ Time Frame: Baseline through 14 days ]Participants who achieve a resolution of CRS. Resolution of CRS is defined as absence of symptoms leading to diagnosis of CRS for 24 hours.
- Participants with a response for Immune effector Cell Associated Neurotoxicity Syndrome (ICANS) [ Time Frame: Baseline through 28 days ]Participants who achieve a resolution or improvement in their ICANS. Complete response or partial response for ICANS is defined as either complete disappearance or decrease in the grade of severity as measured by ASTCT Consensus Grading for ICANS. The ASTCT grade is from 1 to 5 for ICANS with 1 being mild symptoms and 5 being severe symptoms.
- Participants experiencing adverse events from Siltuximab [ Time Frame: Baseline through 28 days ]All Adverse Events (AE's) will be reported and evaluated using National Cancer Institute's Common Terminology Criteria (CTCAE) v5.0.
- Participants with response to CAR T-cell therapy [ Time Frame: Baseline through day 90 ]This will be measured by using specific criteria's for Lymphoma, Multiple Myeloma or Acute Lymphoblastic Leukemia (ALL) [Based on the patients diagnosis]
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): NCT04975555
|Contact: Mayur Narkhedefirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator: Mayur S Narkhede, M.D|
|Sub-Investigator: Amitkumar Mehta, M.D|
|Sub-Investigator: Gaurav Goyal, M.D|
|Sub-Investigator: Susan Bal, M.D|
|Sub-Investigator: Pankit Vachhani, M.D|
|Sub-Investigator: Smith Giri, M.D|
|Principal Investigator:||Mayur S Narkhede||University of Alabama at Birmingham|