Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT05256641
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (acalabrutinib)
    Beginning day 90, patients receive acalabrutinib PO QD and then PO BID once no longer on prophylactic antifungal (CYP34A inhibitors) until day 365 in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group II (acalabrutinib)
    Beginning day 60, patients receive acalabrutinib PO QD and then PO BID from day 74 if there are no dose reductions until day 365 in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group III (acalabrutinib)
    Beginning anytime between days 28-104, patients receive acalabrutinib PO BID until day 365 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Permanent discontinuation of acalabrutinib [ Time Frame: Up to 12 months from cellular therapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Vlad Kustanovich
[email protected]
310-206-5756
Caspian Oliai, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Joseph M. Tuscano
[email protected]
916-734-3772
Joseph M. Tuscano (PRINCIPAL_INVESTIGATOR)
University of OklahomaOklahoma CityOklahoma73190
Matthew J. Wieduwilt
[email protected]
405-217-8001
Matthew J. Wieduwilt (PRINCIPAL_INVESTIGATOR)

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UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Oklahoma· Oklahoma City, OK

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