Recruitment

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