🏛️ Verified NIH Record • Updated 2026-08-27

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (NCT05963074)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: The Oncology Institute Clinical Research — Cerritos, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (74 Sites)

  • The Oncology Institute Clinical Research — Cerritos, California
  • Cancer and Blood Specialty Clinic — Los Alamitos, California
  • SLO Oncology and Hematology Health Center — San Luis Obispo, California
  • Providence Medical Foundation — Santa Rosa, California
  • PIH Health Hospital — Whittier, California
  • Grand Valley Oncology — Grand Junction, Colorado
  • Mount Sinai Medical Center Campus — Miami Beach, Florida
  • The Oncology Institute — North Miami Beach, Florida
  • Mid Florida Hematology Oncology — Orange, Florida
  • Boise VA Medical Center — Boise, Idaho
  • Hope and Healing Cancer Services — Hinsdale, Illinois
  • Springfield Clinic — Springfield, Illinois
  • Iowa City VA Health Care System — Iowa City, Iowa
  • Minnesota Oncology Hematology P A — Minneapolis, Minnesota
  • Research Medical Center — Kansas City, Missouri
  • Hunterdon Hematology Oncology — Flemington, New Jersey
  • Summit Medical Group — Florham Park, New Jersey
  • Hematology Oncology Associates of Rockland — Nyack, New York
  • Southeastern Medical Oncology Center — Goldsboro, North Carolina
  • Oncology Hematology Care — Cincinnati, Ohio
  • Willamette Valley Cancer Institute and Research Center — Eugene, Oregon
  • OHSU Knight Cancer Institute — Portland, Oregon
  • Renovatio Clinical — El Paso, Texas
  • Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas
  • The University of Texas MD Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗