
Identifying Eligible Patients
Key Inclusion Criteria:
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1. Age of 18 years or older. |
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2. Confirmed grade 1-3A FL or MZL according to World Health Organization 2016 classification. All three subtypes of MZL (extranodal, nodal and splenic) are eligible. |
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3. Previously treated with at least one line of systemic therapy including an anti-CD20 monoclonal antibody, with documented failure to achieve remission during the most recent therapy or documented progressive disease after the most recent systemic therapy. (Systemic therapy cannot include Helicobacter pylori eradication or local involved field radiotherapy.) |
Key Exclusion Criteria:
- Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma or grade 3B FL. If transformation is suspected, a biopsy of the suspected area is required to exclude transformation.
- Requiring ongoing need for corticosteroid treatment, except for adrenal replacement. NOTE: Systemic corticosteroids must be fully tapered off / stopped 5 days before the first dose of study treatment.
- Clinically significant cardiovascular disease including the following:
- Myocardial infarction ≤6 months before screening.
- Unstable angina ≤3 months before screening.
- New York Heart Association class 3 or 4 congestive heart failure.
- History of clinically significant arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation or torsade de pointes).
- QT interval corrected using Fridericia's formula (i.e., QTcF) >480 msec.
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place.
- Uncontrolled hypertension as indicated by ≥2 consecutive blood pressure measurements showing systolic blood pressure >170 mm Hg and diastolic blood pressure >105 mm Hg at screening.

MED-US-BGB-3111-2400010