Recruiting
Phase 2

Acalabrutinib & Rituximab

Sponsor:

AstraZeneca

Code:

NCT05952024

Conditions

Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Acalabrutinib

Rituximab

Study Details

Brief summary:

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.

Conditions

Diffuse Large B-Cell Lymphoma

Study ID

NCT05952024

Start date

Jul 16, 2024

Status verified date

Sep, 2026

Completion date

Apr 22, 2029

Anticipated

Primary completion date

Apr 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acalabrutinib and Rituximab

Patients will receive Dose A of acalabrutinib orally in X dosing schedule beginning on Cycle 1 Day 1 for a maximum of 28 cycles or until 2014 Lugano Classification for Non-Hodgkin's Lymphoma (NHL)-defined disease progression or another discontinuation criterion is met. Patients will also receive an intravenous (IV) infusion of Dose B rituximab on Cycle 1 Day 15 and Dose C of rituximab as an subcutaneous (SC) injection on Day 1 of Cycle 2 through Cycle 8.

Interventions

Acalabrutinib

Patients will receive acalabrutinib orally with dosing schedule of X.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Des Moines, Iowa, United States, 50309

Research Site

Recruiting

Tacoma, Washington, United States, 98405

More Information

Sponsor

AstraZeneca

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Chemoimmunotherapy treatments
  • Treatment-naïve elderly patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-04.