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Not recruiting
Phase 2

Ibrutinib

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05963074

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ibrutinib

Venetoclax

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Small Lymphocytic Lymphoma

Study ID

NCT05963074

Start date

May 30, 2024

Status verified date

Jul, 2026

Completion date

Mar 19, 2029

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

333 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax

Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.

experimental: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax

Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.

experimental: Cohort 2a: Continuous Ibrutinib Monotherapy

Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.

experimental: Cohort 2b: Continuous Ibrutinib Monotherapy

Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity.

Interventions

Ibrutinib

Ibrutinib capsules will be administered orally.

Venetoclax

Venetoclax tablets will be administered orally.

Primary outcome measure

  • Best Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-07-31.