Study on Acalabrutinib and Rituximab for Untreated Elderly and/or Frail Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05952024

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment using acalabrutinib and rituximab for elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL) who have not received any prior treatment and are not suitable for standard chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective a combination of acalabrutinib and rituximab is for treating elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL) who have not been treated before and cannot undergo standard chemotherapy. The study will last up to 108 weeks for each participant, including a screening period and treatment with both drugs.

Description

In this study, elderly and/or frail patients with DLBCL who have not received any previous treatment will be given a combination of acalabrutinib and rituximab. The study will last up to 108 weeks for each participant, which includes up to 28 days for screening and 104 weeks of treatment and follow-up. Participants will receive up to 8 cycles of rituximab and 28 cycles of acalabrutinib, both starting at the first cycle.

Eligibility Criteria

Inclusion Criteria

  • Aged 80 years or older, or aged 65 to 79 and not eligible for standard chemotherapy.
  • Diagnosed with diffuse large B-cell lymphoma (DLBCL).
  • No previous treatment for DLBCL.
  • Cancer is at stage II, III, or IV according to the Ann Arbor Classification.
  • Good overall health with a performance status score of 0, 1, or 2, with no recent decline due to reasons other than lymphoma.
  • At least one tumor that can be measured accurately by scans.
  • Adequate organ and bone marrow function without needing growth factors or transfusions within a week before screening.

Exclusion Criteria

  • Have severe or uncontrolled diseases that make participation unsafe or affect compliance with the study.
  • Have another cancer that affects compliance or interpretation of results.
  • Have active hepatitis B or C infection.
  • Have tested positive for HIV.
  • Have active lymphoma in the central nervous system or spinal cord.
  • Have a high score on a health rating scale indicating severe comorbidities.
  • Have a history of a specific brain infection or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
  • Have had a stroke or brain bleeding within 6 months before starting the study.
  • Have a bleeding disorder like hemophilia.
  • Are receiving other cancer treatments.
  • Have had major surgery within 30 days before starting the study or plan to have major surgery during the study.
  • Are taking blood thinners like warfarin.
  • Have received a live virus vaccine within 28 days before starting the study.

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