A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
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|ClinicalTrials.gov Identifier: NCT04148430|
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|B Cell ALL B-Cell Lymphoma B-cell Non Hodgkin Lymphoma||Drug: Anakinra||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Speciifc Chimeric Antigen Receptor (CAR) T Cells|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Cohort 1
Participants will receive anakinra 100mg subcutaneous ever 12 hours starting on day 2 after T cell infusion, or after 2 consecutive documented favers of >/=38.5 degrees Celsius, whichever time point is earlier. Anakinra will be continued until day 10 in the absence of a fever, or until the resolution of fever, defined as temperature </= 38.0 degrees Celsius for at least 24 hours.
Experimental: Cohort 2
If Cohort 1 is considered promising with respect to neurotoxicity and with complete disease response rates 30% or above, then enrollment to Cohort 2 will commence.
In Cohort 2, participants will receive anakinra 100mg subcutaneous daily on day 0 of T cell infusion and will continue daily doses until day 6. If participants experience fever or neurotoxicity between days 0 and 6 the dose of anakinra will be escalated to 100mg subcutaneous ever 12 hours, and participants will follow the same treatment schedule per Cohort 1.
- Rate of Severe Neurotoxicities [ Time Frame: 4 weeks ]Determine the rate of severe neurotoxicities, >/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells
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): NCT04148430
|Contact: Jae Park, MDemail@example.com|
|Contact: Bianca Santomasso, MD, PhD||646-888-2092||SantomaB@mskcc.org|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jae Park, MD 212-639-4048|
|Principal Investigator:||Jae Park, MD||Memorial Sloan Kettering Cancer Center|