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Acalabrutinib and Rituximab for Untreated Elderly DLBCL

This study is looking at a combination of two drugs, acalabrutinib and rituximab, for older patients with diffuse large B-cell lymphoma (DLBCL) who haven't had treatment before and may not be able to receive standard chemotherapy. The goal is to see how safe and effective this combination is. Acalabrutinib is given by mouth, and rituximab is given through an IV and then by injection. The study will measure side effects (adverse events) to understand the safety of this treatment. You might be able to join if you are 65 to 99 years old, have DLBCL, and haven't been treated for it yet. The study is for those with Stage II, III, or IV disease.

Study design
This is a single-arm study, meaning all participants will receive the same treatment. It plans to enroll 80 patients.
What's involved
You would receive acalabrutinib daily and rituximab for up to 8 cycles. The total study duration, including screening and follow-up, could be up to 108 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 3.5 years after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05952024

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

Recruiting
PHASE2Ages 65–99InterventionalTreatment
AstraZeneca
~80 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:AcalabrutinibRituximab

At a glance

Recruiting sites
6 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Measured over Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)

Conditions

Diffuse Large B-Cell Lymphoma

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Diffuse Large B-Cell Lymphoma

NCT05952024

Where you'd take part

This study runs at 57 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Des Moines, Iowano site contact published

    Recruiting

  • Research Site

    Tacoma, Washingtonno site contact published

    Recruiting

  • Research Site

    Brasília, Brazilno site contact published

    Recruiting

  • Research Site

    Florianópolis, Brazilno site contact published

    Recruiting

  • Research Site

    Busan, South Koreano site contact published

    Recruiting

  • Research Site

    Seoul, South Koreano site contact published

    Recruiting

  • Research Site

    Berkeley, Californiano site contact published

    Withdrawn

  • Research Site

    La Jolla, Californiano site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

≥ 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

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 trial measures

  • Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)