Clinical trial · Interventional
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study
NCT06471738CI-TRIAL-00118578recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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) .
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ann Arbor Stage II Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage III Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage IV Follicular Lymphoma | — | UNRESOLVED | — |
| Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Grade 3a Follicular Lymphoma | Grade 3a Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (zanubrutinib, venetoclax, rituximab)
- description
- stage I (cycles 1-3, every 4 weeks): zanubrutinib PO 160mg, BID; rituximab IV on day 1. stage II (cycles 4-9, every 4 weeks): if complete response : zanubrutinib PO 160mg, BID; rituximab IV on day 1. if no complete response : zanubrutinib PO160mg, BID; rituximab IV on day 1 and Venetoclax PO (100mg D1, 200mg D2, and 400mg D3 of cycle 4; 400mg QD).
- interventionNames
- Drug: Zanubrutinib
- Biological: Rituximab
- Drug: Venetoclax
Primary outcomes (1)
- measure
- CR rate
- timeFrame
- Within 6 months of therapy completion
- description
- Determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with a CR will be tabulated.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.