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NCT04148430 Clinical Trial

A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy

B-Cell Lymphoma Clinical Trial

Official title:
A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04148430
Other study ID # 19-168
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 30, 2019
Est. completion date October 2024

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 62
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients (age >/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study Exclusion Criteria: - Patients with uncontrolled systemic fungal and bacterial infections - Patients with known hypersensitivity to E. coli-derived proteins - Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) - Women who are pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Anakinra
100mg subcutaneous

Locations
Country Name City State
United States Hackensack Meridian Health (Data collection only) Hackensack New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities 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 4 weeks
Primary Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment. 28 days from the start of treatment
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