RecruitingPhase 2NCT06471738
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
Sponsor
Chinese PLA General Hospital
Enrollment
30 participants
Start Date
Jul 10, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria19
- 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
- Night sweats
- 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
- Platelets ≤ 100 x 10\^9/L
- 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
Exclusion Criteria15
- ECOG≤ 2
- Absolute neutrophil count (ANC) \> 1.0 x 10\^9/L
- Platelet count \> 50 x 10\^9/L
- 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 upper limit of normal (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
- 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.
Interventions
DRUGZanubrutinib
BTK inhibitor
BIOLOGICALRituximab
Monoclonal antibody to CD20
DRUGVenetoclax
BCL-2 inhibitor
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06471738
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