Study to Personalize Ibrutinib Treatment for Patients with Untreated Chronic Lymphocytic Leukemia

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT05963074

Provider View

This clinical trial is testing different ways to use the drug ibrutinib, alone or with venetoclax, to treat patients with chronic lymphocytic leukemia (CLL) who have not received treatment before. The study aims to find the best dosing strategy by adjusting the medication based on side effects.

Patient Parameters

Program Overview

The goal of this study is to see how effective and safe it is to use ibrutinib, either by itself or with another drug called venetoclax, for treating chronic lymphocytic leukemia (CLL). The study will look at different ways to adjust the dose of ibrutinib, either by reducing it in advance or changing it if side effects occur.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on specific medical guidelines.
  • For those receiving ibrutinib and venetoclax: must be in good health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • For those receiving ibrutinib alone: must have a performance status of 0 to 2, meaning fully active or capable of all self-care but unable to carry out any work activities.
  • Must have at least one lymph node that is 1.5 cm or larger, as seen on a CT scan.
  • If using oral contraceptives, must use an additional method of birth control.
  • Must agree not to be pregnant, breastfeeding, or planning to become pregnant during the study and for a specified time after the last dose.

Exclusion Criteria

  • Have uncontrolled autoimmune conditions affecting blood cells, such as autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, requiring high doses of steroids.
  • Have known bleeding disorders like von Willebrand's disease or hemophilia.
  • Have had a stroke or bleeding in the brain within the last 6 months.
  • Have a known or suspected transformation of CLL to a more aggressive form or involvement of the central nervous system.
  • Have active and significant heart disease, such as uncontrolled irregular heartbeats or severe heart failure.

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