BTK inhibition

The key inclusion criteria are –

• Men and women, aged ≥18 and ≤75 years
• Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review
• No prior treatment for DLBCL
• ECOG PS of ≤2
• International Prognostic Index (IPI) score of 1 to 5
• Disease Stage II to IV by the Ann Arbor Classification
• Adequate organ and marrow function
• Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab

Reference:

Study NCT04529772. ClinicalTrials.gov website.

The key exclusion criteria are –

• Evidence of severe or uncontrolled systemic diseases
• Known history of a bleeding diathesis (ie, hemophilia, von Willebrand disease)
• History of stroke or intracranial hemorrhage in preceding 6 months 
• Known CNS lymphoma or leptomeningeal disease, primary mediastinal lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, indolent lymphoma or CLL and ongoing confirmed PML
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
• Uncontrolled active systemic fungal, bacterial, viral, or other infection
• Prior anthracycline use ≥150 mg/m²