Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL

Part of paid clinical trials in Berkeley, California.

Sponsor
AstraZeneca
Study ID
NCT05952024
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Patients will receive acalabrutinib orally with dosing schedule of X.
  • Rituximab — BIOLOGICAL
    Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.

Study Details

The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.

Key Dates

Start date
Jul 16, 2024
Status verified
May 2026
Primary completion
Apr 22, 2029
Completion
Apr 22, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib and Rituximab
    Patients will receive Dose A of acalabrutinib orally in X dosing schedule beginning on Cycle 1 Day 1 for a maximum of 28 cycles or until 2014 Lugano Classification for Non-Hodgkin's Lymphoma (NHL)-defined disease progression or another discontinuation criterion is met. Patients will also receive an intravenous (IV) infusion of Dose B rituximab on Cycle 1 Day 15 and Dose C of rituximab as an subcutaneous (SC) injection on Day 1 of Cycle 2 through Cycle 8.

Primary Outcome Measure

Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Research SiteBerkeleyCalifornia94704-
Research SiteLa JollaCalifornia92093-
Research SiteOrangeCalifornia92868-
Research SiteStamfordConnecticut06902-
Research SiteJacksonvilleFlorida32256-
Research SiteDes MoinesIowa50309-
Research SiteLexingtonKentucky40536-
Research SiteBeltsvilleMaryland20705-
Research SiteTowsonMaryland21204-
Research SiteDetroitMichigan48202-
Research SiteSioux FallsSouth Dakota57104-
Research SiteLubbockTexas79410-
Research SiteOlympiaWashington98506-
Research SiteTacomaWashington98405-

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