🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06471738
Recruiting Phase 2

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

NCT06471738 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Phase 2
Started
2024-07-10
Last updated
2026-07-20

Condition(s) studied

Ann Arbor Stage II Follicular LymphomaGrade 1 Follicular LymphomaAnn Arbor Stage III Follicular LymphomaAnn Arbor Stage IV Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular Lymphoma

Investigational drug(s) / intervention(s)

Zanubrutinib →Rituximab →Venetoclax →

Zanubrutinib: BTK inhibitor

Rituximab: Monoclonal antibody to CD20

Venetoclax: BCL-2 inhibitor

Study summary

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) .

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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 Criteria: * Known active central nervous system lymphoma or leptomeningeal disease * Follicular lymphoma with evidence of diffuse large B-cell transformation * Grade 3b follicular lymphoma * Any prior history of other malignancy besides follicular lymphoma * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * Patients who have undergone major surgery within 14 days * The researchers believe that it is not advisable for the participant to take part in this trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital Beijing China Recruiting

On this site

📄 Brukinsa (zanubrutinib) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Venclexta (venetoclax) drug profile →

More Chinese PLA General Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471738 on ClinicalTrials.gov ↗ ← All trials in China