A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
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|ClinicalTrials.gov Identifier: NCT04150913|
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : July 9, 2020
This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL).
- Relapsed NHL is the condition of returned Non-Hodgkin lymphoma.
- Refractory NHL is the condition of previous treatment resistant Non-Hodgkin lymphoma.
- Cytokine Release Syndrome (CRS) is a group of side effect symptoms that can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash.
- Neurologic toxicity is nervous system disorder characterized by confusion
This research study involves two drugs:
- Axicabtagene Ciloleucel.
|Condition or disease||Intervention/treatment||Phase|
|Non Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Relapsed Non Hodgkin Lymphoma Neurotoxicity Neurotoxicity Syndromes Cytokine Release Syndrome||Drug: Anakinra Drug: Axicabtagene Ciloleucel||Phase 2|
This Phase 2, single center, open-label research study is studying the combination of Anakinra and Axicabtagene Ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities in people with relapsed or refractory Non-Hodgkin lymphoma (NHL).
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
This research study involves two drugs:
- Axicabtagene Ciloleucel
- A total of 20 participants will be enrolled to this trial
- The U.S. Food and Drug Administration (FDA) has not approved anakinra for use in treatment of Non-Hodgkin lymphoma (NHL).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2024|
Experimental: Anakinra and Axicabtagene Ciloleucel
Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment.
Subcutaneous, dosage per protocol. Day 0 through Day 6.
Other Name: Kineret®
Drug: Axicabtagene Ciloleucel
Once, intravenous infusion, dosage per protocol
- Rate of neurotoxicity as per CTCAE v4.03 criteria [ Time Frame: 30 Days ]The incidence of grade 2+ neurotoxicity will be assessed in comparison to a historical rate of 45% via a two-sized exact binomial test with significant level of 0.05.
- Objective Response Rate [ Time Frame: 24 Months ]The incidence of objective response and exact 2-sided 95% confidence intervals will be generated
- Duration of Response [ Time Frame: first objective response to disease progression death regardless of cause up 100 Months ]Cumulative incidence of relapse.
- Progression-free Survival [ Time Frame: infusion date to the date of disease progression or death from any cause up 100 Months ]Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for progression-free survival time
- Overall Survival [ Time Frame: time from axicabtagene ciloleucel infusion to the date of death or analysis data cutoff date will be censored at last contact date up to 100 months. ]Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for OS.
- Number of Participants with Adverse Events CTCAE version 4.03 Grade 3 or higher [ Time Frame: 24 Months ]Subject incidence rates of adverse events including all, serious, fatal, CTCAE version 4.03 Grade 3 or higher and treatment related AEs reported throughout the conduct of the study will be tabulated by preferred term and system organ class
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): NCT04150913
|Contact: Matt J Frigault, MD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: Matt Frigault, MD 617-643-6175|
|Principal Investigator: Matt Frigault, MD|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Contact: Caron Jacobson, MD 617-632-5847 email@example.com|
|Principal Investigator: Caron Jacobson, MD|
|Principal Investigator:||Matt J Frigault, MD||Massachusetts General Hospital|