Zanubrutinib, rituximab and venetoclax for untreated follicular lymphoma
Tests zanubrutinib, rituximab and venetoclax in adults with untreated follicular lymphoma.
Plain-language title generated from the registry record
Registry title: Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Where in China
- Biotherapeutic Department and Hematology Department of Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT06471738
- Record updated
- 20 July 2026
- Original description
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) .Read full original descriptionShow less
Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study
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) .
Inclusion: 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 the following criteria:; Presence of at least one B symptom: 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/dL, or Platelets ≤ 100 x 10\^9/L, or Absolute neutrophil count (ANC) < 1.5 x 10\^9/L; Pleural or peritoneal effusion; Lactate dehydrogenase (LDH) > upper limit of normal (ULN) or beta (B)2 microglobulin > ULN; Other lymphoma-mediated symptoms as determined by the treating physician; ECOG ≤ 2; ANC > 1.0 x 10\^9/L (for patients without bone marrow involvement by lymphoma); Platelet count > 50 x 10\^9/L (for patients without bone marrow involvement by lymphoma); Prothrombin time (PT)/international normal ratio (INR) < 1.5 x (upper limit of normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin or other vitamin K antagonists, then INR ≤ 3.0); Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x ULN; Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula; Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL; Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study.
Exclusion: Patients who have undergone major surgery within 14 days; Known active central nervous system lymphoma or leptomeningeal disease; Any prior history of other malignancy besides follicular lymphoma; History of severe allergic or anaphylactic reactions to monoclonal antibody therapy; Follicular lymphoma with evidence of diffuse large B-cell transformation; Grade 3b follicular lymphoma; The researchers believe that it is not advisable for the participant to take part in this trial.