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Clinical Trials in Canada / NCT05963074
Active, not recruiting Phase 2

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

NCT05963074 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-05-30
Last updated
2026-09-25

Condition(s) studied

Leukemia, Lymphocytic, Chronic, B-CellSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

Ibrutinib →Venetoclax →

Ibrutinib: Ibrutinib capsules will be administered orally.

Venetoclax: Venetoclax tablets will be administered orally.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
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
Renovatio Clinical 1 The Woodlands Texas
Texas Oncology-Gulf Coast The Woodlands Texas
Community Cancer Trials of Utah Ogden Utah
Virginia Cancer Specialists Manassas Virginia
Virginia Oncology Associates Virginia Beach Virginia
VA Puget Sound Healthcare System Seattle Washington
Northwest Cancer Specialists PC Vancouver Washington
QEII Health Sciences Centre Halifax Nova Scotia
Niagara Health System St. Catharines Ontario
Fakultni nemocnice Brno Brno-Bohunice Czechia
Fakultni nemocnice Hradec Kralove Hradec Králové Czechia
Fakultni nemocnice Olomouc Olomouc Czechia
Fakultni Nemocnice Ostrava Ostrava - Poruba Czechia
Fakultni nemocnice Kralovske Vinohrady Prague Czechia
Ustav Hematologie A Krevni Transfuze Prague Czechia

+ 34 more sites — see the full list on the official registry below.

On this site

📄 Imbruvica (ibrutinib) drug profile → 📄 Venclexta (venetoclax) drug profile →

More Janssen Research & Development, LLC trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05963074 on ClinicalTrials.gov ↗ ← All trials in Canada