Actively Recruiting
Efficacy and Safety of Zanubrutinib, Rituximab, and Lenalidomide (ZR²) Combined With Tislelizumab for Relapsed/Refractory Follicular Lymphoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-02-18
33
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a combination treatment including zanubrutinib, rituximab, lenalidomide (ZR²), and tislelizumab in patients with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy. This Phase II, single-center, open-label study aims to understand how well this regimen works and how safe it is for these patients. Participants will receive six 21-day treatment cycles of the four-drug combination during the induction phase. Zanubrutinib is taken orally twice daily, rituximab is given intravenously on specific days during cycles 1 to 6 and possibly beyond, lenalidomide is taken orally once daily during cycles 1 to 6, and tislelizumab is infused intravenously every three weeks. After induction, patients who achieve complete response, partial response, or stable disease will enter maintenance therapy with zanubrutinib and tislelizumab for up to one year or until progression or unacceptable side effects. Throughout the study, patients will undergo disease assessments by CT or PET-CT scans to evaluate tumor response using the 2014 Lugano criteria. Safety and efficacy will be closely monitored, including response rates and progression-free survival up to two years. Treatment-related adverse events will be recorded from the first dose until 30 days after stopping treatment. The total study duration includes induction, maintenance, and follow-up periods as outlined in the protocol.
CONDITIONS
Brief Title
Efficacy and Safety of Zanubrutinib, Rituximab, and Lenalidomide (ZR²) in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Age 18 to 75 years
- Histologically confirmed relapsed/refractory follicular lymphoma
- Received at least two prior lines of systemic therapy including anti-CD20 monoclonal antibody therapy
- ECOG performance status of 0 or 1
- Measurable disease with longest diameter greater than 1.5 cm
- Estimated life expectancy of at least 18 weeks
- Adverse events from prior therapy resolved to grade 1 or less (except alopecia and anorexia)
- Adequate hepatic function with specified bilirubin and liver enzyme limits
- Adequate hematologic function with specified ANC, platelet, and hemoglobin levels without recent transfusions
- Adequate renal function as measured by serum creatinine or creatinine clearance
- For women of childbearing potential: negative pregnancy test and agreement to use contraception or abstinence
- For men: agreement to use contraception or abstinence
You will not qualify if you...
- Unable to comply with required hospitalization and study restrictions
- Active infection or latent tuberculosis
- History of severe allergic reactions to similar drugs
- Current involvement of the central nervous system
- Pregnant or breastfeeding women
- Uncontrolled medical conditions such as recent serious cardiac events
- Illicit drug use or alcohol abuse within 12 months prior to screening
- Any condition or laboratory abnormality suggesting contraindication to study drugs
- Psychiatric or cognitive disorders limiting consent or compliance
- Planning pregnancy during the study period
- Prior exposure to zanubrutinib or other BTK inhibitors
- Intolerable toxicity from prior BTK inhibitor treatment
- Received fewer than two consecutive study drug administrations after enrollment
- Protocol violations
- Prior hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 cycles (3 weeks per cycle)
Participants receive a combination of four drugs (tislelizumab, zanubrutinib, rituximab, and lenalidomide) over 6 cycles. Each cycle lasts 3 weeks.
6 cycles with visits on Day 1 of each cycle for infusions and daily oral medications during cycles
Duration - Up to 1 year
Participants who respond to induction therapy receive maintenance treatment with zanubrutinib and tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.
Intravenous infusions every 3 weeks and daily oral medication with zanubrutinib
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
J
Jinhua Liang
W
Wei Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here