Actively Recruiting
Safety and Efficacy of Zanubrutinib with Rituximab and Venetoclax in Untreated Follicular Lymphoma: Open Label Phase 2 Study
Led by Chinese PLA General Hospital · Updated on 2024-07-18
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Follicular lymphoma (FL) is a common slow-growing type of non-Hodgkin's lymphoma with variable progression. This trial aims to study the safety and effectiveness of combining zanubrutinib, venetoclax, and rituximab as a first treatment for patients with untreated FL. The study focuses on a chemotherapy-free regimen to reduce toxicity while assessing treatment feasibility and response. Participants receive treatment in two stages: In cycles 1 to 3 (every 4 weeks), zanubrutinib is taken orally twice daily and rituximab is given intravenously on day 1. In cycles 4 to 9 (every 4 weeks), if a complete response is achieved, zanubrutinib and rituximab continue as before. If no complete response, venetoclax is added orally in increasing doses starting cycle 4 while continuing zanubrutinib and rituximab. During the study, participants will be regularly evaluated for treatment response, side effects, and overall health. Researchers will measure the complete response rate within 6 months after therapy completion, along with other outcomes like overall response rate, progression-free survival, overall survival, and treatment-emergent adverse events up to 90 days after the last dose. The total follow-up period extends up to two years to monitor long-term effects and safety.
CONDITIONS
Brief Title
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with untreated follicular lymphoma (grades 1, 2, or 3a)
- Stage II, III, or IV disease
- Able and willing to provide written informed consent and comply with the study protocol
- Have at least one measurable disease
- Need therapy based on at least one of these: B symptoms (fever >38°C not due to infection, night sweats, weight loss >10% in 6 months), fatigue from lymphoma, splenomegaly >13 cm, compression syndrome, lymphoma-related cytopenias (hemoglobin ≤10 g/dL, platelets ≤100 x 10^9/L, ANC <1.5 x 10^9/L), pleural or peritoneal effusion, elevated LDH or beta-2 microglobulin, or other lymphoma symptoms as judged by physician
You will not qualify if you...
- ECOG performance status greater than 2
- ANC greater than 1.0 x 10^9/L
- Platelet count greater than 50 x 10^9/L
- Prothrombin time/INR ≥ 1.5 x ULN or aPTT ≥ 1.5 x ULN unless unrelated to bleeding disorder; INR ≤ 3.0 if on warfarin
- AST and ALT levels 3 times above ULN
- Creatinine clearance less than or equal to 30 ml/min
- Bilirubin greater than 1.5 x ULN unless due to Gilbert's syndrome, liver lymphoma, or non-hepatic causes (bilirubin ≤3 g/dL in those cases)
- Women of childbearing potential who are pregnant or breastfeeding
- Known active central nervous system lymphoma or leptomeningeal disease
- Follicular lymphoma with diffuse large B-cell transformation
- Grade 3b follicular lymphoma
- Prior history of other malignancies besides follicular lymphoma
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Major surgery within 14 days before participation
- Any condition deemed by researchers to make participation inadvisable
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 cycles of 4 weeks each (approximately 36 weeks)
Participants receive zanubrutinib orally twice daily and rituximab intravenously every 4 weeks for cycles 1-3. From cycles 4-9, participants with complete response continue zanubrutinib twice daily and rituximab every 4 weeks. Participants without complete response receive zanubrutinib twice daily, rituximab every 4 weeks, and venetoclax orally with a ramp-up dosing during cycle 4 and daily thereafter.
1 visit every 4 weeks for up to 9 cycles
Duration - Up to 2 years after treatment completion
Participants are monitored for treatment-emergent adverse events and long-term outcomes after completing therapy.
Visits up to 90 days after last dose for adverse event monitoring; additional visits for survival follow-up as scheduled
Trial Site Locations
Total: 1 location
1
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China, 100853
Actively Recruiting
Research Team
Y
YANG LIU, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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