A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 99
Healthy Volunteers: f
View:

• ≥ 80 years of age at the time of screening, or

• ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy

• Histologically documented DLBCL

• No prior treatment for DLBCL

• Stage II, III, or IV disease by the Ann Arbor Classification .

• Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.

• At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.

• Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.

Locations
United States
California
Research Site
RECRUITING
La Jolla
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Orange
Connecticut
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WITHDRAWN
Stamford
Florida
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RECRUITING
Jacksonville
Iowa
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Waukee
Kentucky
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WITHDRAWN
Lexington
Maryland
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Baltimore
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Rockville
Michigan
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Detroit
South Dakota
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WITHDRAWN
Sioux Falls
Texas
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Lubbock
Washington
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Olympia
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Tacoma
Other Locations
Brazil
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Distrito Federal
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Distrito Federal
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Distrito Federal
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Goiás
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Maranhão
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Minas Gerais
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Paranã
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Pernambuco
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Rio De Janeiro
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Rio Grande
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Rio Grande
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Rio Grande Do Norte
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Santa Catarina
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São Paulo
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COMPLETED
São Paulo
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São Paulo
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São Paulo
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São Paulo
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São Paulo
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São Paulo
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São Paulo
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São Paulo
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São Paulo
Puerto Rico
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San Juan
Republic of Korea
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Busanjin-gu
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Dalseo-gu
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Dong-gu
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Gangnam-gu
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Gyeonggi-do
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Gyeongsangnam-do
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Jeollabuk-do
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Namdong-gu
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Seo-gu
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Seo-gu
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Seocho-gu
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Seodaemun-gu
Research Site
RECRUITING
Songpa-gu
Research Site
RECRUITING
Yangch’ŏn-gu
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2027-08-24
Participants
Target number of participants: 80
Treatments
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.
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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