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New treatment option for Leukemia, Lymphocytic, Chronic, B-Cell
Official title A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05963074
What this study is testing
What is Ibrutinib?
Ibrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leukemia, lymphocytic, chronic, b-cell.
Also referred to as JNJ-54179060, IMBRUVICA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL)...
- For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG...
- Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (\>=) 1.5 centimeters (cm) in...
- 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...
You likely can't join if
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cerritos, California, United States
- Los Alamitos, California, United States
- San Luis Obispo, California, United States
- Santa Rosa, California, United States
- Whittier, California, United States
- Grand Junction, Colorado, United States
- Miami Beach, Florida, United States
- North Miami Beach, Florida, United States
- Orange, Florida, United States
- Boise, Idaho, United States
- Hinsdale, Illinois, United States
- Springfield, Illinois, United States
- Iowa City, Iowa, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Flemington, New Jersey, United States
- Florham Park, New Jersey, United States
- Nyack, New York, United States
- Goldsboro, North Carolina, United States
- Cincinnati, Ohio, United States
+ 49 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cerritos, California, United States; Los Alamitos, California, United States; San Luis Obispo, California, United States; Santa Rosa, California, United States; Whittier, California, United States; Grand Junction, Colorado, United States and 63 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.