Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma

Inclusion criteria

• Willing to participate in the clinical study and signed informed consent.
• Age ≥18 years, no gender restrictions.
• Pathologically diagnosed with follicular lymphoma (Grade 1, 2, or 3a) and previously untreated.
• Has at least one measurable or assessable lesion.
• Ann-Arbor stage III or IV, or stage II with bulky disease.
• Meets at least one GELF criterion.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
• Adequate major organ function.

Exclusion criteria

• Known active central nervous system lymphoma or leptomeningeal disease.
• Evidence of follicular lymphoma with transformation to diffuse large B-cell lymphoma.
• Prior history of other malignancies other than follicular lymphoma (except for those with disease-free survival ≥5 years and assessed by the investigator as having low risk of recurrence).
• History of allergy to the investigational drug, similar drugs, or excipients.
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
• Active systemic infection requiring intravenous antibiotic therapy or hospitalization (occurring within 4 weeks prior to screening).
• Confirmed progressive multifocal leukoencephalopathy (PML), positive for human T-lymphotropic virus type 1 (HTLV-1), or suspected active/latent tuberculosis.
• Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
• Patients with significant dysfunction of vital organs.
• Receipt of any moderate or strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of sotoclax.
• Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 7 days prior to the first dose of zanubrutinib, or requirement for continuous use of strong CYP3A inhibitors/inducers.
• Receipt of concurrent therapy for the study disease outside of this clinical study (including the screening period).
• Autoimmune anemia and/or thrombocytopenia that does not respond adequately to corticosteroids or other standard treatments.
• Receipt of medications known to prolong the QT/QTc interval.
• Vaccination with a live vaccine within ≤35 days prior to the first dose of study drug.
• Major surgery within 4 weeks prior to the first dose of study drug.
• Unwillingness or inability to complete all assessments and procedures required by the study.