NCT05952024From ClinicalTrials.govRecruiting

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)

Diffuse Large B-Cell Lymphoma

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AstraZeneca
Enrolment target: 80
Started: 16 July 2024
Main results due: 22 April 2029
Study sites: 57
Registry updated: 29 September 2026

Can you take part?

Ages 65 years to 99 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(57)

Research Site
Berkeley, California, United States
Withdrawn
Research Site
La Jolla, California, United States
Completed
Research Site
Orange, California, United States
Withdrawn
Research Site
Stamford, Connecticut, United States
Withdrawn
Research Site
Jacksonville, Florida, United States
Active, not recruiting
Research Site
Des Moines, Iowa, United States
Recruiting
Research Site
Lexington, Kentucky, United States
Withdrawn
Research Site
Beltsville, Maryland, United States
Active, not recruiting
Research Site
Towson, Maryland, United States
Active, not recruiting
Research Site
Detroit, Michigan, United States
Active, not recruiting
Research Site
Sioux Falls, South Dakota, United States
Withdrawn
Research Site
Lubbock, Texas, United States
Active, not recruiting
Research Site
Olympia, Washington, United States
Active, not recruiting
Research Site
Tacoma, Washington, United States
Recruiting
Research Site
Barretos, Brazil
Active, not recruiting
Research Site
Belo Horizonte, Brazil
Active, not recruiting
Research Site
Brasília, Brazil
Active, not recruiting
Research Site
Brasília, Brazil
Recruiting
Research Site
Brasília, Brazil
Active, not recruiting
Research Site
Campinas, Brazil
Active, not recruiting
Research Site
Curitiba, Brazil
Active, not recruiting
Research Site
Florianópolis, Brazil
Active, not recruiting
Research Site
Florianópolis, Brazil
Active, not recruiting
Research Site
Goiânia, Brazil
Active, not recruiting
Research Site
Natal, Brazil
Active, not recruiting
Research Site
Porto Alegre, Brazil
Active, not recruiting
Research Site
Porto Alegre, Brazil
Active, not recruiting
Research Site
Recife, Brazil
Active, not recruiting
Research Site
Ribeirão Preto, Brazil
Active, not recruiting
Research Site
Rio de Janeiro, Brazil
Active, not recruiting
Research Site
São José do Rio Preto, Brazil
Active, not recruiting
Research Site
São Luís, Brazil
Active, not recruiting
Research Site
São Paulo, Brazil
Active, not recruiting
Research Site
São Paulo, Brazil
Active, not recruiting
Research Site
São Paulo, Brazil
Active, not recruiting
Research Site
São Paulo, Brazil
Completed
Research Site
São Paulo, Brazil
Active, not recruiting
Research Site
Sorocaba, Brazil
Active, not recruiting
Research Site
San Juan, Puerto Rico
Active, not recruiting
Research Site
Busan, South Korea
Recruiting
Research Site
Busan, South Korea
Active, not recruiting
Research Site
Daegu, South Korea
Active, not recruiting
Research Site
Gyeongsangnam-do, South Korea
Active, not recruiting
Research Site
Incheon, South Korea
Active, not recruiting
Research Site
Jeonju, South Korea
Active, not recruiting
Research Site
Seogu, South Korea
Active, not recruiting
Research Site
Seoul, South Korea
Active, not recruiting
Research Site
Seoul, South Korea
Active, not recruiting
Research Site
Seoul, South Korea
Active, not recruiting
Research Site
Seoul, South Korea
Recruiting
Research Site
Seoul, South Korea
Active, not recruiting
Research Site
Suwon, South Korea
Active, not recruiting
Research Site
Ulsan, South Korea
Active, not recruiting
Research Site
Kaohsiung City, Taiwan
Withdrawn
Research Site
Kaohsiung City, Taiwan
Withdrawn
Research Site
Tainan, Taiwan
Withdrawn
Research Site
Taipei, Taiwan
Withdrawn

Showing 57 of 57 sites. 5 of the 57 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05952024. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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