A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

BeiGene, Ltd.0 sites600 target enrollmentNovember 13, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Each patient eligible to participate in this study must meet ALL of the following criteria:
•1\. Age 18 years or older
•2\. Confirmed diagnosis of CLL or SLL that meets the IWCLL criteria 3\. CLL/SLL requiring treatment as defined by at least 1 of the following criteria:
•a. Evidence of progressive marrow failure as manifested by the development of, or
•worsening of, anemia and/or thrombocytopenia
•b. Massive (\= 6 cm below left costal margin), progressive, or symptomatic splenomegaly
•c. Massive nodes (\= 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy
•d. Progressive lymphocytosis with an increase of \> 50% over a 2\-month period or lymphocyte\-doubling time of \< 6 months. Lymphocyte\-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of \< 30 x 10 9/L (30,000/µL), lymphocyte\-doubling time should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (eg, infection) should be excluded.
•e. Constitutional symptoms, defined as any 1 or more of the following disease\-related symptoms or signs:
•i. Unintentional weight loss of \= 10% within the previous 6 months

•Each patient eligible to participate in this study must NOT meet any of the following exclusion criteria:
•1\. Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation (biopsy based on clinical suspicion may be needed to rule out transformation)
•2\. Clinically significant cardiovascular disease including the following:
•a. Myocardial infarction within 6 months before screening
•b. Unstable angina within 3 months before screening
•c. New York Heart Association class III or IV congestive heart failure
•d. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)
•e. QTcF \> 480 milliseconds based on Fridericia’s formula
•f. History of Mobitz II second\-degree or third\-degree heart block without a permanent pacemaker in place
•g. Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg at screening