Pre-emptive Anakinra for Cytokine Event Reduction (PACER)

Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cytokine Release Syndrome; Immune Effector Cell Associated Neurotoxicity Syndrome; CAR-T Cell Therapy; B-Acute Lymphoblastic Leukemia; Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome
• Intervention / Treatment: Drug: Anakinra (Kineret®)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kevin O McNerney, MD; Phone Number: 312-227-4090; Email: kmcnerney@luriechildrens.org
• Study Contact Backup: Name: Eric Brown; Phone Number: 312-227-4871; Email: errbrown@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Eric Brown; Phone Number: 312-227-4871; Email: errbrown@luriechildrens.org
      • Contact: Kevin McNerney, MD; Phone Number: 312-227-4859; Email: kmcnerney@luriechildrens.org
      • Principal Investigator: Kevin McNerney, MD
      • Sub-Investigator: Sonali Chaudhury, MD
      • Sub-Investigator: Jennifer Schneiderman, MD
      • Sub-Investigator: Veronika Polishchuk, MD
      • Sub-Investigator: Hannah Lust, MD
      • Sub-Investigator: Xiaopei Zeng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

• Patient consent and parental assent will be obtained.

NOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.

• Patients or their parents/legally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.
• The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.

Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
• POCBP 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)
• Patients who are between the age of 1 to 26 years

• Relapsed or refractory B-acute lymphoblastic leukemia

  • 2nd or greater marrow relapse OR
  • Central nervous system (CNS) relapse OR
  • Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR
  • Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR

  • Ineligible for allogeneic HSCT because of:

    • Comorbid disease
    • Other contraindications to allogeneic HSCT conditioning
    • No suitable donor
    • Prior HSCT
    • Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician
  • Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.

• Adequate organ function defined as:

  • Alanine aminotransferase (ALT) < 500 U/L
  • Bilirubin ≤2.0 mg/dL
  • Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry >92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.
  • Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.
  • Serum creatinine below the values in the below table, based on age/sex assigned at birth: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 1 to <2 0.6 0.6 2 to <6 0.8 0.8 6 to <10 1.0 1.0 10 to <13 1.2 1.2 13 to <16 1.5 1.4 ≥16 1.7 1.4
• Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy
• Receiving commercially available tisagenlecleucel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Drug: Anakinra (Kineret®); Pre-emptive Anakinra at the initial onset of CRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Severe CRS within 30 days of CAR T-cell infusion	The rate of severe CRS, grade ≥3 CRS, as defined by the American Society of Transplantation and Cellular Therapy (ASTCT) consensus guidelines. Participants will have CRS grading each day of hospitalization and every clinical visit within the first 30 days of CAR T-cell infusion.	30 days of CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission Rate	1. Complete Remission Rate at day 28-35 post-CAR-T	28-35 days post CAR-T infusion
Overall and event-free survival	6- and 12-month overall and event-free survival	Up to 12 months post CAR-T infusion
CRS and ICANS Severity	Rate and any grade of CRS, any grade ICANS, severe (grade >/=3) ICANS, any grade IEC-HS	Up to 12 months post CAR-T infusion
Immune effector cell-associated hematotoxicity (ICAHT) Severity	Rate of any grade and grade >/=3 ICAHT as defined by European Hematology Association (EHA)/European Society for Blood and Marrow Transplantation (EBMT) guidelines	Up to 12 months post CAR-T infusion
Use of tocilizumab or steroids	Use of tocilizumab and steroids in the treatment of CRS, ICANS, or Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS)	Within 30 days post CAR T infusion
Infection severity	Rate of severe infections (as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade >/=3)	Within 30 days post CAR T infusion
Inflammatory markers and cell turnover	Inflammatory markers (C-reactive protein, ferritin) and markers of cell turnover (lactate dehydrogenase and uric acid)	Within 30 days post CAR T infusion
Cell expansion and plasma cytokine profiles	CAR T-cell expansion and plasma cytokine profiles	Within 35 days post CAR T infusion

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Center for Advancing Translational Sciences (NCATS)

Publications and helpful links

General Publications

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• Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. doi: 10.1056/NEJMoa1709866.
• Gazeau N, Liang EC, Wu QV, Voutsinas JM, Barba P, Iacoboni G, Kwon M, Ortega JLR, Lopez-Corral L, Hernani R, Ortiz-Maldonado V, Martinez-Cibrian N, Martinez AP, Maziarz RT, Williamson S, Nemecek ER, Shadman M, Cowan AJ, Green DJ, Kimble E, Hirayama AV, Maloney DG, Turtle CJ, Gauthier J. Anakinra for Refractory Cytokine Release Syndrome or Immune Effector Cell-Associated Neurotoxicity Syndrome after Chimeric Antigen Receptor T Cell Therapy. Transplant Cell Ther. 2023 Jul;29(7):430-437. doi: 10.1016/j.jtct.2023.04.001. Epub 2023 Apr 7.
• Rejeski K, Subklewe M, Aljurf M, Bachy E, Balduzzi A, Barba P, Bruno B, Benjamin R, Carrabba MG, Chabannon C, Ciceri F, Corradini P, Delgado J, Di Blasi R, Greco R, Houot R, Iacoboni G, Jager U, Kersten MJ, Mielke S, Nagler A, Onida F, Peric Z, Roddie C, Ruggeri A, Sanchez-Guijo F, Sanchez-Ortega I, Schneidawind D, Schubert ML, Snowden JA, Thieblemont C, Topp M, Zinzani PL, Gribben JG, Bonini C, Sureda A, Yakoub-Agha I. Immune effector cell-associated hematotoxicity: EHA/EBMT consensus grading and best practice recommendations. Blood. 2023 Sep 7;142(10):865-877. doi: 10.1182/blood.2023020578.
• Kineret. Package Insert. Biovitrum AB. December 18th.
• Strati P, Jallouk A, Deng Q, Li X, Feng L, Sun R, Adkins S, Johncy S, Cain T, Steiner RE, Ahmed S, Chihara D, Fayad LE, Iyer SP, Horowitz S, Nastoupil LJ, Nair R, Hassan A, Daoud TE, Hawkins M, Rodriguez MA, Shpall EJ, Ramdial JL, Kebriaei P, Hong DS, Westin JR, Neelapu SS, Green MR. A phase 1 study of prophylactic anakinra to mitigate ICANS in patients with large B-cell lymphoma. Blood Adv. 2023 Nov 14;7(21):6785-6789. doi: 10.1182/bloodadvances.2023010653. No abstract available.
• Liang EC, Albittar A, Portuguese AJ, Huang JJ, Wuliji N, Wu Q, De Los Reyes J, Pin N, Torkelson A, Kirchmeier DR. Planned Interim Analysis of a Phase 2 Investigator-Initiated Trial of Anakinra to Prevent CRS and Neurotoxicity after Treatment with Lisocabtagene Maraleucel. Transplantation and Cellular Therapy. 2024;30(2):S179-S80.
• Frigault MJ, Gallagher KM, Wehrli M, Valles B, Casey K, Lindell K, Trailor M, Cho H, Brown JL, Horick NK. A phase II trial of anakinra for the prevention of CAR-T cell mediated neurotoxicity. Blood. 2021;138:2814.
• Park JH, Nath K, Devlin SM, Sauter CS, Palomba ML, Shah G, Dahi P, Lin RJ, Scordo M, Perales MA, Shouval R, Tomas AA, Cathcart E, Mead E, Santomasso B, Holodny A, Brentjens RJ, Riviere I, Sadelain M. CD19 CAR T-cell therapy and prophylactic anakinra in relapsed or refractory lymphoma: phase 2 trial interim results. Nat Med. 2023 Jul;29(7):1710-1717. doi: 10.1038/s41591-023-02404-6. Epub 2023 Jul 3.
• Hines MR, Keenan C, Maron Alfaro G, Cheng C, Zhou Y, Sharma A, Hurley C, Nichols KE, Gottschalk S, Triplett BM, Talleur AC. Hemophagocytic lymphohistiocytosis-like toxicity (carHLH) after CD19-specific CAR T-cell therapy. Br J Haematol. 2021 Aug;194(4):701-707. doi: 10.1111/bjh.17662. Epub 2021 Jul 15.
• Dreyzin A, Jacobsohn D, Angiolillo A, Wistinghausen B, Schore RJ, Perez E, Wells E, Terao J, Bonifant C, Rohatgi R, Dave H, Vatsayan A. Intravenous anakinra for tisagenlecleucel-related toxicities in children and young adults. Pediatr Hematol Oncol. 2022 May;39(4):370-378. doi: 10.1080/08880018.2021.1988012. Epub 2021 Oct 21. No abstract available.
• Lichtenstein DA, Schischlik F, Shao L, Steinberg SM, Yates B, Wang HW, Wang Y, Inglefield J, Dulau-Florea A, Ceppi F, Hermida LC, Stringaris K, Dunham K, Homan P, Jailwala P, Mirazee J, Robinson W, Chisholm KM, Yuan C, Stetler-Stevenson M, Ombrello AK, Jin J, Fry TJ, Taylor N, Highfill SL, Jin P, Gardner RA, Shalabi H, Ruppin E, Stroncek DF, Shah NN. Characterization of HLH-like manifestations as a CRS variant in patients receiving CD22 CAR T cells. Blood. 2021 Dec 16;138(24):2469-2484. doi: 10.1182/blood.2021011898.
• Diorio C, Vatsayan A, Talleur AC, Annesley C, Jaroscak JJ, Shalabi H, Ombrello AK, Hudspeth M, Maude SL, Gardner RA, Shah NN. Anakinra utilization in refractory pediatric CAR T-cell associated toxicities. Blood Adv. 2022 Jun 14;6(11):3398-3403. doi: 10.1182/bloodadvances.2022006983. No abstract available.
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• Hines MR, von Bahr Greenwood T, Beutel G, Beutel K, Hays JA, Horne A, Janka G, Jordan MB, van Laar JAM, Lachmann G, Lehmberg K, Machowicz R, Miettunen P, La Rosee P, Shakoory B, Zinter MS, Henter JI. Consensus-Based Guidelines for the Recognition, Diagnosis, and Management of Hemophagocytic Lymphohistiocytosis in Critically Ill Children and Adults. Crit Care Med. 2022 May 1;50(5):860-872. doi: 10.1097/CCM.0000000000005361. Epub 2021 Oct 5.
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Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Prophylaxis; Anakinra; Cytokine Release Syndrome; CAR-T Therapy; B-acute lymphoblastic leukemia; Inflammatory Toxicity; Immune Effector Cell Associated Neurotoxicity Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Disease; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Chemically-Induced Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Poisoning; Shock; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Cytokine Release Syndrome; Syndrome; Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neurotoxicity Syndromes; Lymphohistiocytosis, Hemophagocytic; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: 2024-7158; K12TR005104 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No