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

NCT05963074 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

Ibrutinib

Ibrutinib capsules will be administered orally.

DRUG

Venetoclax

Venetoclax tablets will be administered orally.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2027-12-15
Completion
2029-03-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05963074 on ClinicalTrials.gov