A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cytokine Release Syndrome
- Neurotoxicity
- Neurotoxicity Syndromes
- Non Hodgkin Lymphoma
- Refractory Non Hodgkin Lymphoma
- Relapsed Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 rese...
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: Anakinra 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).
Tracking Information
- NCT #
- NCT04150913
- Collaborators
- Kite, A Gilead Company
- Investigators
- Principal Investigator: Matt J Frigault, MD Massachusetts General Hospital