Tests acalabrutinib with rituximab in older or frail people with lymphoma
Tests acalabrutinib plus rituximab in older or frail adults newly diagnosed with lymphoma.
Plain-language title generated from the registry record
Registry title: Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Key facts
- Where
- San Juan, Puerto RicoSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 65 and 99 years old?
Source: NCT05952024, who can take part
Where in Puerto Rico
- San JuanSan Juan, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT05952024
- Record updated
- 30 October 2026
- Original 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.Read full original descriptionShow less
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)
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.
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: History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results; History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug; 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; 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; 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 bleeding diathesis (eg, haemophilia, von Willebrand disease).