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Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

StatusRecruiting
PhasePhase 2
Started2024-07-10
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Status, Eligibility v2
Eligibility criteria+75 characters
Inclusion Criteria: A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated. Stage II, III, or IV disease. Able and willing to provide written informed consent and to comply with the study protocol. at least one measurable disease. Must be in need of therapy as evidenced by at least one of [...] tom: Fever (> 38 Celsius [C]) not due to infectious etiology, or Night sweats, or Weight loss > 10% in the past 6 months; Fatigue due to lymphoma; Splenomegaly (> 13 cm); Compression syndrome (ureteral, orbital, gastrointestinal); Any of the following cytopenias, due to lymphoma: Hemoglobin ≤ 10 g [...] [...]
2024-07-16
Study Identification, Study Status, Arms and Interventions, Outcome Measures v1
Start dateestimated 2024-07-01→confirmed 2024-07-10
Secondary endpoints4 entries, revised
SafetyIncidence of studyTreatment-Emergent treatmentsAdverse Events
Study title-24 characters
A Phase ll Trial of the Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
2024-06-18
Original filing
This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .
Trial Details
NCT Number NCT06471738
Lead Sponsor Chinese PLA General Hospital
Conditions Ann Arbor Stage II Follicular Lymphoma, Grade 1 Follicular Lymphoma, Ann Arbor Stage III Follicular Lymphoma, Ann Arbor Stage IV Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3a Follicular Lymphoma
Enrollment 30 participants
Start Date 2024-07-10
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-20