Home › Trials › NCT05963074

Customizing Ibrutinib Treatment for Chronic Lymphocytic Leukemia

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia

Phase 2 Interventional Janssen Research & Development, LLC · NCT05963074

This study is testing two different ways to use the drug ibrutinib for people with newly diagnosed chronic lymphocytic leukemia to see which method works best and is safest.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsibruinib, ibrutinib, prednisone
Locations73 sites (Cerritos, California and 72 other locations)
Trial IDNCT05963074 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of two treatment regimens for patients with previously untreated chronic lymphocytic leukemia (CLL) using ibrutinib, both in combination with venetoclax and as a standalone therapy. The dosing of ibrutinib will be adjusted either proactively or reactively based on the occurrence of adverse events. Participants will be monitored for measurable nodal disease to assess treatment response. The study aims to optimize treatment strategies for better patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma who meet specific performance status criteria.

Not a fit: Patients with uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment regimens for patients with chronic lymphocytic leukemia.

How similar studies have performed: Other studies have shown promise in using personalized treatment approaches for CLL, suggesting potential success for this novel methodology.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria
* For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2
* Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (\>=) 1.5 centimeters (cm) in longest diameter
* A participant using oral contraceptives must use an additional contraceptive method
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States)

Exclusion Criteria:

* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (\>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease
* Known bleeding disorders (example, von Willebrand's disease or hemophilia)
* Stroke or intracranial hemorrhage within 6 months prior to enrollment
* Known or suspected Richter's transformation or central nervous system (CNS) involvement
* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification

Where this trial is running

Cerritos, California and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Leukemia, Lymphocytic, Chronic, B-CellSmall Lymphocytic Lymphoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.