NCT05952024

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm. Study details include the following: * The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up. * The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-16
• Primary completion: 2027-08-24
• Completion: 2027-08-24
• First posted: 2023-07-19
• Last updated: 2025-12-22

Locations

48 sites across 4 countries: United States, Brazil, Puerto Rico, South Korea

Regulatory

• FDA-regulated drug study