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NCT05952024PHASE2Recruiting

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

AstraZeneca

Start Date

7/16/2024

Completion Date

4/22/2029

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.

Detailed Description

Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm. 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.

Eligibility Criteria

Age Range: 65 years to 99 years

Inclusion Criteria: * ≥ 80 years of age at the time of screening, or * ≥ 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: * Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol. * 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.

Interventions

DRUG

Acalabrutinib

BIOLOGICAL

Rituximab

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Conditions

Diffuse Large B-Cell Lymphoma

Locations

Research Site

Berkeley, California 94704

United States

Research Site

La Jolla, California 92093

United States

Research Site

Orange, California 92868

United States

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Stamford, Connecticut 06902

United States

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Jacksonville, Florida 32256

United States

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Des Moines, Iowa 50309

United States

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Lexington, Kentucky 40536

United States

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Beltsville, Maryland 20705

United States

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Towson, Maryland 21204

United States

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Detroit, Michigan 48202

United States

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Sioux Falls, South Dakota 57104

United States

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Lubbock, Texas 79410

United States

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Olympia, Washington 98506

United States

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Tacoma, Washington 98405

United States

Research Site

Barretos, 14784-400

Brazil

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Belo Horizonte, 30150-221

Brazil

Research Site

Brasília, 70200-730

Brazil

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Brasília, 70390-700

Brazil

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Brasília, 70840-901

Brazil

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Campinas, 13060-803

Brazil

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Curitiba, 81520-060

Brazil

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Florianópolis, 88020-210

Brazil

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Florianópolis, 88034-000

Brazil

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Goiânia, 74605-020

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 90035-003

Brazil

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Porto Alegre, 90880-480

Brazil

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Recife, 50070-480

Brazil

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Ribeirão Preto, 14048-900

Brazil

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Rio de Janeiro, 20231-050

Brazil

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São José do Rio Preto, 15090-000

Brazil

Research Site

São Luís, 65060-645

Brazil

Research Site

São Paulo, 01229-010

Brazil

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São Paulo, 01409-02

Brazil

Research Site

São Paulo, 05652-900

Brazil

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São Paulo, 08270-070

Brazil

Research Site

São Paulo, 1323000

Brazil

Research Site

Sorocaba, 18030-005

Brazil

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San Juan, 00917

Puerto Rico

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Busan, 47392

South Korea

Research Site

Busan, 49241

South Korea

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Daegu, 42601

South Korea

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Gyeongsangnam-do, 52727

South Korea

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Incheon, 405-760

South Korea

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Jeonju, 54907

South Korea

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Seogu, 49201

South Korea

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Seoul, 03722

South Korea

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Seoul, 05505

South Korea

Research Site

Seoul, 06351

South Korea

Research Site

Seoul, 06591

South Korea

Research Site

Seoul, 07985

South Korea

Research Site

Suwon, 16499

South Korea

Research Site

Ulsan, 44033

South Korea

Research Site

Kaohsiung City, 80756

Taiwan

Research Site

Kaohsiung City, 833

Taiwan

Research Site

Tainan, 736

Taiwan

Research Site

Taipei, 100

Taiwan