Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma (NCT07550855) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma
China52 participantsStarted 2026-09-01
Plain-language summary
Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. This underscores the need for more effective and better-tolerated frontline treatment strategies, particularly chemotherapy-free approaches. The present study is based on a strong biologic rationale that simultaneously targets two key pathogenic mechanisms in FL: aberrant B-cell receptor signaling and impaired apoptosis driven by BCL2 overexpression. Zanubrutinib, a next-generation BTK inhibitor, has shown clinical activity with a favorable safety profile in FL, while sonrotoclax, a potent and highly selective next-generation BCL2 inhibitor, has demonstrated promising preclinical and early clinical activity. In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.
Who can participate
Age range18 Years
SexALL
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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.