A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
a study on Chronic Lymphocytic Leukemia Leukemia Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Irvine UCLA
- Dates
- study startedestimated completion
Description
Summary
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Official Title
A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Details
This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.
Keywords
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma CLL SLL relapsed refractory Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Zanubrutinib Ibrutinib
Eligibility
You can join if…
Open to people ages 18 years and up
- Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
- CLL/SLL requiring treatment per 2008 IWCLL criteria
- Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
- Measurable disease by CT/magnetic resonance imaging (MRI)
- ECOG performance status of 0, 1, or 2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate renal and hepatic function
You CAN'T join if...
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Clinically significant cardiovascular disease.
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast
- History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- Severe or debilitating pulmonary disease
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Known central nervous system involvement by leukemia or lymphoma
- Known infection with HIV or active viral hepatitis B or C infection
- . Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
- . Major surgery within 4 weeks of the first dose of study drug
- . Prior treatment with a BTK inhibitor
- . Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
- . Pregnant or lactating women
- . Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- . Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
- . Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
- David Geffen School of Medicine at UCLA
accepting new patients
Los Angeles California 90095 United States - University of California Irvine Medical Center
accepting new patients
Orange California 92868 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- BeiGene
- ID
- NCT03734016
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated