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RECRUITING
NCT05952024
PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

65 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-07-16

Completion Date

2027-08-24

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

Acalabrutinib

Patients will receive acalabrutinib orally with dosing schedule of X.

BIOLOGICAL

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.

Locations (48)

Research Site

La Jolla, California, United States

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Orange, California, United States

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Jacksonville, Florida, United States

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Waukee, Iowa, 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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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

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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

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Busanjin-gu, Busan, South Korea

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Seo-gu, Busan, South Korea

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Seo-gu, Busan, South Korea

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Dalseo-gu, Daegu, South Korea

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Namdong-gu, Incheon, South Korea

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Jeollabuk-do, Jeonju-si, South Korea

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Gyeongsangnam-do, Jinju-si, South Korea

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Gangnam-gu, Seoul, South Korea

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Seocho-gu, Seoul, South Korea

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Seodaemun-gu, Seoul, South Korea

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Songpa-gu, Seoul, South Korea

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Yangch’ŏn-gu, Seoul, South Korea

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Gyeonggi-do, Suwon-si, South Korea

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Dong-gu, Ulsan, South Korea