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Treatment for elderly patients with untreated diffuse large B-cell lymphoma

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)

Phase 2 Interventional AstraZeneca · NCT05952024

This study is testing a new treatment combining acalabrutinib and rituximab for older or frail patients with untreated diffuse large B-cell lymphoma to see if it works better than standard chemotherapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages65 Years to 99 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsrituximab, acalabrutinib
Locations57 sites (Berkeley, California and 56 other locations)
Trial IDNCT05952024 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and efficacy of acalabrutinib combined with rituximab in elderly and/or frail patients who have not received prior treatment for diffuse large B-cell lymphoma (DLBCL). The trial focuses on patients who are unsuitable for standard chemoimmunotherapy, aiming to provide an alternative treatment option. Participants will undergo treatment for up to 104 weeks, with assessments of their response to the therapy throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 65 and older with untreated DLBCL who are considered ineligible for standard chemoimmunotherapy.

Not a fit: Patients with severe uncontrolled systemic diseases or those who have received prior treatment for DLBCL may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for elderly patients with DLBCL who cannot tolerate traditional therapies.

How similar studies have performed: Other studies have shown promise in using targeted therapies like acalabrutinib for similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Berkeley, California and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diffuse Large B-Cell LymphomaChemoimmunotherapy treatmentsTreatment-naïve elderly patients
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.