NCT05952024 · AstraZeneca
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
(ACRUE)
What this study is about
The study will measure the safety, tolerability, and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Acalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.
BIOLOGICAL
Rituximab
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.
Primary outcome measures
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Berkeley, California
- La Jolla, California
- Orange, California
- Stamford, Connecticut
- Jacksonville, Florida
- Des Moines, Iowa
- Lexington, Kentucky
- Beltsville, Maryland
- Towson, Maryland
- Detroit, Michigan
- Sioux Falls, South Dakota
- Lubbock, Texas
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations