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

Last Updated   April 25, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    22 sites
  • Status
    Recruiting

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

ELIGIBILITY

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

DETAILS

LOCATIONS

Locations in:
United States, Spain
Country (2) City or Province (22) Status
United States Cerritos, CA The Oncology Institute Clinical Research
RECRUITING
United States Cincinnati, OH Oncology Hematology Care
RECRUITING
United States Eugene, OR Willamette Valley Cancer Institute and Research Center
RECRUITING
United States Flemington, NJ Hunterdon Hematology Oncology
RECRUITING
United States Fort Worth, TX Texas Oncology-Fort Worth Cancer Center
RECRUITING
United States Gainesville, VA Virginia Cancer Specialists
RECRUITING
United States Goldsboro, NC Southeastern Medical Oncology Center
RECRUITING
United States Grand Junction, CO Grand Valley Oncology
RECRUITING
United States Hinsdale, IL Hope and Healing Cancer Services
RECRUITING
United States Iowa City, IA Iowa City VA Health Care System
RECRUITING
United States Kansas City, MO Research Medical Center
RECRUITING
United States Miami Beach, FL Mount Sinai Medical Center Campus
RECRUITING
United States Minneapolis, MN Minnesota Oncology Hematology, P.A.
RECRUITING
United States Ogden, UT Community Cancer Trials of Utah
RECRUITING
United States Santa Rosa, CA Providence Medical Foundation
RECRUITING
United States Seattle, WA VA Puget Sound Healthcare System
RECRUITING
United States Springfield, IL Springfield Clinic
RECRUITING
United States The Woodlands, TX Texas Oncology-Gulf Coast
RECRUITING
United States Vancouver, WA Northwest Cancer Specialists PC
RECRUITING
United States Virginia Beach, VA Virginia Oncology Associates
RECRUITING
United States Whittier, CA PIH Health Hospital
RECRUITING
Spain Santander, CT Hosp. Univ. Marques de Valdecilla
RECRUITING
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5

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