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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• B Cell ALL
• B-Cell Lymphoma
• B-cell Non Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell

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

External Links

•   Memorial Sloan Kettering Cancer Center