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

NCT05952024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2029-03-25
Completion
2029-03-25
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Puerto Rico
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952024 on ClinicalTrials.gov