ACTIVE_NOT_RECRUITING

Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma

Conditions

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma Progressive Disease Recurrent Diffuse Large B-Cell Lymphoma Recurrent High Grade B-Cell Lymphoma Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory High Grade B-Cell Lymphoma Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.

Official Title

IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome

Quick Facts

Study Start:2020-03-04

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04205838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with relapsed or refractory large B-cell lymphoma that has progressed on two prior lines of therapy, who meet the indication for the Food and Drug Administration (FDA)-approved therapy axicabtagene ciloleucel * Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma * The above includes patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation * Patients with central nervous system (CNS) involvement of large B-cell lymphoma that originated outside of the CNS will be included (not primary CNS lymphoma) * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 upper limit of normal * Total bilirubin =\< 2.0 mg/dL * Creatinine clearance \> 30 mL/min based on Cockcroft-Gault formula * Patients with human immunodeficiency virus (HIV) who have an undetectable viral load will be included * Deemed competent to make medical decisions	* Patients who receive CAR T-cell therapy with a product other than axicabtagene ciloleucel * Primary CNS lymphoma * Transformed DLBCL from chronic lymphocytic leukemia (CLL) * Burkitt?s lymphoma * Bridging chemotherapy completed \< 7 days prior to CAR T-cell lymphodepleting chemotherapy * In patients who receive bridging chemotherapy, positron emission tomography (PET)-computed tomography (CT) or CT of chest, abdomen, pelvis was not done after bridging chemotherapy prior lympho-depleting therapy * Most recent PET-CT or CT of all known disease is sites done more than 6 weeks prior to CAR T-cell infusion * Any individual CNS tumor mass \> 2 cm * History of autologous hematopoietic stem cell transplantation administered less than 100 days prior to CAR T-cell infusion * History of allogeneic hematopoietic stem cell transplantation * Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis * Less than 3 half-lives elapsed since receiving immune checkpoint inhibitor (pembrolizumab, ipilimumab, nivolumab, atezolizumab, etc.) * Presence of uncontrolled fungal, bacterial, or viral infection that require intravenous (IV) antimicrobial treatment * History of autoimmune disease resulting in end-organ damage, or autoimmune disease requiring systemic immunosuppressants or disease-modifying antirheumatic drug (DMARDs) within the past 6 months * Hypersensitivity to E. Coli-derived proteins * Patients with HIV who have a detectable viral load * Pregnant or nursing * Fertile women who decline use of contraception during the study period

Inclusion Criteria

Exclusion Criteria

* Patients with relapsed or refractory large B-cell lymphoma that has progressed on two prior lines of therapy, who meet the indication for the Food and Drug Administration (FDA)-approved therapy axicabtagene ciloleucel
* Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
* The above includes patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation
* Patients with central nervous system (CNS) involvement of large B-cell lymphoma that originated outside of the CNS will be included (not primary CNS lymphoma)
* Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 upper limit of normal
* Total bilirubin =\< 2.0 mg/dL
* Creatinine clearance \> 30 mL/min based on Cockcroft-Gault formula
* Patients with human immunodeficiency virus (HIV) who have an undetectable viral load will be included
* Deemed competent to make medical decisions

* Patients who receive CAR T-cell therapy with a product other than axicabtagene ciloleucel
* Primary CNS lymphoma
* Transformed DLBCL from chronic lymphocytic leukemia (CLL)
* Burkitt?s lymphoma
* Bridging chemotherapy completed \< 7 days prior to CAR T-cell lymphodepleting chemotherapy
* In patients who receive bridging chemotherapy, positron emission tomography (PET)-computed tomography (CT) or CT of chest, abdomen, pelvis was not done after bridging chemotherapy prior lympho-depleting therapy
* Most recent PET-CT or CT of all known disease is sites done more than 6 weeks prior to CAR T-cell infusion
* Any individual CNS tumor mass \> 2 cm
* History of autologous hematopoietic stem cell transplantation administered less than 100 days prior to CAR T-cell infusion
* History of allogeneic hematopoietic stem cell transplantation
* Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
* Less than 3 half-lives elapsed since receiving immune checkpoint inhibitor (pembrolizumab, ipilimumab, nivolumab, atezolizumab, etc.)
* Presence of uncontrolled fungal, bacterial, or viral infection that require intravenous (IV) antimicrobial treatment
* History of autoimmune disease resulting in end-organ damage, or autoimmune disease requiring systemic immunosuppressants or disease-modifying antirheumatic drug (DMARDs) within the past 6 months
* Hypersensitivity to E. Coli-derived proteins
* Patients with HIV who have a detectable viral load
* Pregnant or nursing
* Fertile women who decline use of contraception during the study period

Contacts and Locations

Principal Investigator

John M Timmerman, MD

PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UC Davis Comprehensive Cancer Center

Davis, California, 95817

United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

John M Timmerman, MD, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-04

Study Completion Date2027-06

Study Record Updates

Study Start Date2020-03-04

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
High Grade B-Cell Lymphoma
Progressive Disease
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma
Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma