RecruitingPhase 2NCT05952024

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

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)

Sponsor

AstraZeneca

Enrollment

80 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 65 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — acalabrutinib and rituximab — as a treatment for elderly or frail patients with diffuse large B-cell lymphoma (DLBCL), an aggressive blood cancer, who have not been treated before but cannot tolerate standard chemotherapy. **You may be eligible if...** - You are 80 years of age or older, OR - You are 65 to 79 years old and your doctor has determined you are not fit enough for standard chemotherapy - You have newly diagnosed DLBCL and have not received any previous treatment for it - You have measurable disease on imaging - Your organ function is adequate **You may NOT be eligible if...** - You have active HIV or hepatitis B or C infection - Your cancer has spread to the brain or spinal fluid - You have had a stroke or brain bleed in the past 6 months - You have a bleeding disorder such as hemophilia - You have received a live vaccine in the past 28 days - You have other serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Patients will receive acalabrutinib orally with dosing schedule of X.

BIOLOGICALRituximab

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)

Research Site

Berkeley, California, United States

Research Site

La Jolla, California, United States

Research Site

Orange, California, United States

Research Site

Stamford, Connecticut, United States

Research Site

Jacksonville, Florida, United States

Research Site

Des Moines, Iowa, United States

Research Site

Lexington, Kentucky, United States

Research Site

Beltsville, Maryland, United States

Research Site

Towson, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

Sioux Falls, South Dakota, United States

Research Site

Lubbock, Texas, United States

Research Site

Olympia, Washington, United States

Research Site

Tacoma, Washington, United States

Research Site

Barretos, Brazil

Research Site

Belo Horizonte, Brazil

Research Site

Brasília, Brazil

Research Site

Brasília, Brazil

Research Site

Brasília, Brazil

Research Site

Campinas, Brazil

Research Site

Curitiba, Brazil

Research Site

Florianópolis, Brazil

Research Site

Florianópolis, Brazil

Research Site

Goiânia, Brazil

Research Site

Natal, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Recife, Brazil

Research Site

Ribeirão Preto, Brazil

Research Site

Rio de Janeiro, Brazil

Research Site

São José do Rio Preto, Brazil

Research Site

São Luís, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Sorocaba, Brazil

Research Site

San Juan, Puerto Rico

Research Site

Busan, South Korea

Research Site

Busan, South Korea

Research Site

Daegu, South Korea

Research Site

Gyeongsangnam-do, South Korea

Research Site

Incheon, South Korea

Research Site

Jeonju, South Korea

Research Site

Seogu, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Suwon, South Korea

Research Site

Ulsan, South Korea

Research Site

Kaohsiung City, Taiwan

Research Site

Kaohsiung City, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05952024

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