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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05256641
Other study ID # 21-000979
Secondary ID NCI-2021-12421
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 23, 2023
Est. completion date October 1, 2025

Study information

Verified date February 2024
Source Jonsson Comprehensive Cancer Center
Contact Vlad Kustanovitch
Phone 310-206-5756
Email VKustanovich@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase Ib/II trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.


Description:

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Study Design


Intervention

Drug:
Acalabrutinib
Given PO

Locations

Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States University of Oklahoma Oklahoma City Oklahoma
United States University of California Davis Comprehensive Cancer Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other CAR T-cell persistence CAR T-cell persistence measured by mass cytometry upon enrollment, 90 days after initiation of acalabrutinib, and at time of relapse. Up to 5 years
Other Immunophenotyping of peripheral blood mononuclear cells Types and numbers of proteins present on the leukemia cell surface via mass cytometry upon enrollment, 90 days after initiation of acalabrutinib, and at time of relapse Up to 5 years
Other Intracellular cytokine and phospho-protein profiling of peripheral blood mononuclear cells Types of proteins involved in cell signaling in leukemia cells via mass cytometry upon enrollment, 90 days after initiation of acalabrutinib, and at time of relapse. Up to 5 years
Other Acalabrutinib metabolite Acalabrutinib metabolite detected in the cerebral spinal fluid at 1-3 weeks after initiation of acalabrutinib in participants with history of secondary central nervous system lymphoma. At 1-3 weeks after initiation of acalabrutinib
Primary Permanent discontinuation of acalabrutinib Tolerability will be determined by the number of patients who permanently discontinue acalabrutinib within 12 months from cellular therapy due to intolerance. The proportion of patients with acalabrutinib discontinuation will be reported along with 95% and 90% confidence intervals. Up to 12 months from cellular therapy
Secondary Progression-free survival (PFS) The 1-year PFS will be evaluated based on progression of disease per Lugano criteria or death, and will be reported based on Kaplan-Meier estimates along with 95% confidence interval. At 12 months from cellular therapy
Secondary PFS Will be reported based on 95% confidence intervals at annual time points. Up to 5 years
Secondary Overall survival Time from cellular therapy to death due to any cause, assessed at 1 and 5 years based on Kaplan-Meier estimates along with 95% confidence interval Up to 5 years
Secondary Rate of conversion from partial response following chimeric antigen receptor (CAR) T-cell therapy to complete response after the addition of acalabrutinib maintenance Will be reported based on 95% confidence intervals. Up to day 365
Secondary Incidence of dose reductions, interruptions, or discontinuations of acalabrutinib based on the protocol criteria Will be reported based on 95% confidence intervals. Up to day 365
Secondary Incidence of graft versus host disease (GvHD) >= stage 2 Based on the Mount Sinai Acute GVHD International Consortium criteria for acute GvHD and the National Institutes of Health consensus criteria for chronic GvHD. Will be reported based on 95% confidence intervals. Up to day 365
Secondary Incidence of hematologic adverse events Based on Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Will be reported based on 95% confidence intervals. Up to day 365
Secondary Incidence of non-hematologic adverse events Based on CTCAE v5.0. Will be reported based on 95% confidence intervals. Up to day 365
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