Pre-emptive Anakinra for Cytokine Event Reduction

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT06703216
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • B-Acute Lymphoblastic Leukemia
  • CAR-T Cell Therapy
  • Cytokine Release Syndrome
  • Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome
  • Immune Effector Cell Associated Neurotoxicity Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Anakinra (Kineret®) — DRUG
    Pre-emptive Anakinra at the initial onset of CRS.

Study Details

Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults. Patient Population: Children and young adults \<25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy. Study Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \>/=5% bone marrow blasts or lymphoblasts in the peripheral blood. Treatment Plan: This is a single arm unblinded study in which patients will receive anakinra, 2.5 mg/kg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg/kg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.

Key Dates

Start date
Aug 31, 2025
Status verified
Jun 2025
Primary completion
Aug 31, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm

Primary Outcome Measure

Rate of Severe CRS within 30 days of CAR T-cell infusion [ Time Frame: 30 days of CAR-T infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Kevin McNerney, MD
[email protected]
312-227-4859
Eric Brown
[email protected]
312-227-4871
Kevin McNerney, MD (PRINCIPAL_INVESTIGATOR)
Sonali Chaudhury, MD (SUB_INVESTIGATOR)
Jennifer Schneiderman, MD (SUB_INVESTIGATOR)
Veronika Polishchuk, MD (SUB_INVESTIGATOR)
Hannah Lust, MD (SUB_INVESTIGATOR)
Xiaopei Zeng, MD (SUB_INVESTIGATOR)

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By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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