A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
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ClinicalTrials.gov Identifier: NCT04150913 |
Recruitment Status :
Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : April 23, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | November 1, 2019 | ||||||||||||||
First Posted Date ICMJE | November 5, 2019 | ||||||||||||||
Last Update Posted Date | April 23, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | October 5, 2020 | ||||||||||||||
Estimated Primary Completion Date | October 30, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Rate of neurotoxicity as per CTCAE v4.03 criteria [ Time Frame: 30 Days ] The incidence of grade 2+ neurotoxicity will be assessed in comparison to a historical rate of 45% via a two-sized exact binomial test with significant level of 0.05.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity | ||||||||||||||
Official Title ICMJE | A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity | ||||||||||||||
Brief Summary | This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL).
This research study involves two drugs:
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Detailed Description | This Phase 2, single center, open-label research study is studying the combination of Anakinra and Axicabtagene Ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities in people with relapsed or refractory Non-Hodgkin lymphoma (NHL). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Anakinra and Axicabtagene Ciloleucel
Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment.
Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
15 | ||||||||||||||
Original Estimated Enrollment ICMJE |
20 | ||||||||||||||
Estimated Study Completion Date ICMJE | October 31, 2025 | ||||||||||||||
Estimated Primary Completion Date | October 30, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04150913 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-348 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Marcela V. Maus, M.D.,Ph.D., Massachusetts General Hospital | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Marcela V. Maus, M.D.,Ph.D. | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Kite, A Gilead Company | ||||||||||||||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | ||||||||||||||
Verification Date | April 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |