Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
NCT ID: NCT05952024
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-07-16
2027-08-24
Brief Summary
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Detailed Description
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Study details include the following:
* The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up.
* The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Acalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.
Rituximab
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.
Interventions
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Acalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.
Rituximab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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.
Exclusion Criteria
* History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
* Serologic status reflecting active hepatitis B or C infection.
* Serological positivity or known infection with HIV.
* Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
* Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \> 17.
* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
* Known active significant infection.
* History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
* History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
* Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
* Received a live virus vaccination within 28 days of the first dose of study drug.
65 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
La Jolla, California, United States
Research Site
Orange, California, United States
Research Site
Stamford, Connecticut, United States
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Jacksonville, Florida, United States
Research Site
Waukee, Iowa, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Detroit, Michigan, United States
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Sioux Falls, South Dakota, United States
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Lubbock, Texas, United States
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Olympia, Washington, United States
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Tacoma, Washington, United States
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São Paulo, Barretos, Brazil
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Minas Gerais, Belo Horizonte, Brazil
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Distrito Federal, Brasilia, Brazil
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Distrito Federal, Brasilia, Brazil
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Distrito Federal, Brasilia, Brazil
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São Paulo, Campinas, Brazil
Research Site
Paranã, Curitiba, Brazil
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Santa Catarina, Florianopolis, Brazil
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Goiás, Goiania, Brazil
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Rio Grande Do Norte, Natal, Brazil
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Rio Grande, Porto Alegre, Brazil
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Rio Grande, Porto Alegre, Brazil
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Pernambuco, Recife, Brazil
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São Paulo, Ribeirao Prieto, Brazil
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São Paulo, Sao Jose Do Rio Preto, Brazil
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Maranhão, Sao Luis, Brazil
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São Paulo, Sorocaba, Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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San Juan, , Puerto Rico
Research Site
Busanjin-gu, Busan, South Korea
Research Site
Seo-gu, Busan, South Korea
Research Site
Seo-gu, Busan, South Korea
Research Site
Dalseo-gu, Daegu, South Korea
Research Site
Namdong-gu, Incheon, South Korea
Research Site
Jeollabuk-do, Jeonju-si, South Korea
Research Site
Gyeongsangnam-do, Jinju-si, South Korea
Research Site
Gangnam-gu, Seoul, South Korea
Research Site
Seocho-gu, Seoul, South Korea
Research Site
Seodaemun-gu, Seoul, South Korea
Research Site
Songpa-gu, Seoul, South Korea
Research Site
Yangch’ŏn-gu, Seoul, South Korea
Research Site
Gyeonggi-do, Suwon-si, South Korea
Research Site
Dong-gu, Ulsan, South Korea
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D8227C00002
Identifier Type: -
Identifier Source: org_study_id