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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04148430
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
B Cell ALL B-Cell Lymphoma B-cell Non Hodgkin Lymphoma Drug: Anakinra Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Speciifc Chimeric Antigen Receptor (CAR) T Cells
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: Cohort 1
Participants will receive anakinra 100mg subcutaneous ever 12 hours starting on day 2 after T cell infusion, or after 2 consecutive documented favers of >/=38.5 degrees Celsius, whichever time point is earlier. Anakinra will be continued until day 10 in the absence of a fever, or until the resolution of fever, defined as temperature </= 38.0 degrees Celsius for at least 24 hours.
Drug: Anakinra
100mg subcutaneous

Experimental: Cohort 2

If Cohort 1 is considered promising with respect to neurotoxicity and with complete disease response rates 30% or above, then enrollment to Cohort 2 will commence.

In Cohort 2, participants will receive anakinra 100mg subcutaneous daily on day 0 of T cell infusion and will continue daily doses until day 6. If participants experience fever or neurotoxicity between days 0 and 6 the dose of anakinra will be escalated to 100mg subcutaneous ever 12 hours, and participants will follow the same treatment schedule per Cohort 1.

Drug: Anakinra
100mg subcutaneous

Primary Outcome Measures :
  1. Rate of Severe Neurotoxicities [ Time Frame: 4 weeks ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients (age >/= 18) with a diagnosis of relapsed CD19+ B-cell ALL or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel and axicabtagene) 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04148430

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Contact: Jae Park, MD 212-639-4048
Contact: Bianca Santomasso, MD, PhD 646-888-2092

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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jae Park, MD    212-639-4048      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Jae Park, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT04148430    
Other Study ID Numbers: 19-168
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents