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Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Sponsor: AstraZeneca
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
Conditions
Interventions
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.
Locations (48)
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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