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Ibrutinib Treatment for Chronic Lymphocytic Leukemia

This study is looking at different ways to use ibrutinib, a medicine, sometimes with another medicine called venetoclax, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who haven't been treated before. Researchers want to see if changing the dose of ibrutinib, either planned ahead of time or in response to side effects, is effective and safe. You can join if you are 18 or older and have been diagnosed with CLL/SLL. The main goal is to see how many people respond to the treatment, measured over up to 5 years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 320 participants. It is evaluating different treatment regimens of ibrutinib, with or without venetoclax.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, Best Overall Response Rate, will be measured for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05963074

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~333 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IbrutinibVenetoclax

At a glance

Recruiting sites
0 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate (ORR)
Measured over Up to 5 years

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

74 sites across 25 states
Italy11
Poland7
Czechia6
France6
Spain6
California5
Texas5
Hungary4

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Best Overall Response Rate (ORR)Up to 5 years

    Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.