A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (TAILOR)
Last Updated   April 25, 2024 - 21:00
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
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
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
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.