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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
2029-03-25
Last Updated
2026-05-05
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 (57)
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Berkeley, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Stamford, Connecticut, United States
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Jacksonville, Florida, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Beltsville, Maryland, United States
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Towson, 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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Barretos, Brazil
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Belo Horizonte, Brazil
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Brasília, Brazil
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Brasília, Brazil
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Brasília, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Florianópolis, Brazil
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Goiânia, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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São José do Rio Preto, Brazil
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São Luís, 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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Sorocaba, Brazil
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San Juan, Puerto Rico
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Busan, South Korea
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Busan, South Korea
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Daegu, South Korea
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Gyeongsangnam-do, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seogu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Ulsan, South Korea
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan