Actively Recruiting
Zanubrutinib for Maintenance Therapy in Patients With Mantle Cell Lymphoma Who Have Remission After First-line Immunochemotherapy- a Multicenter, Prospective, Phase II Study
Led by Fudan University · Updated on 2024-09-04
52
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether maintenance therapy with Zanubrutinib alone can improve the two-year progression-free survival for patients with mantle cell lymphoma who have achieved remission after first-line immunochemotherapy. This study is a multicenter, prospective, phase II trial focusing on patients in remission, aiming to explore the effectiveness and safety of Zanubrutinib maintenance treatment. Patients who achieved complete or partial remission after initial immunochemotherapy, including regimens like R-CHOP or BR, will receive Zanubrutinib monotherapy for up to two years. Treatment will continue until disease progression, intolerable side effects, death, withdrawal, or study termination. This approach allows researchers to assess Zanubrutinib as a maintenance therapy in this patient population. Participants will be monitored over two years, with assessments including progression-free survival, event-free survival, overall survival, toxicity evaluations, and quality of life questionnaires. The study will collect data on blood counts, liver and kidney function, heart function, and coagulation status to ensure safety. The total participation duration may last up to two years, with regular follow-up and safety monitoring throughout the trial period.
CONDITIONS
Brief Title
A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed mantle cell lymphoma
- Achieved complete or partial remission through first-line immunochemotherapy (at least 4 cycles including CD20 monoclonal antibody)
- Previous autologous hematopoietic stem cell transplantation allowed
- ECOG performance status between 0 and 2
- Signed informed consent form
- Sufficient organ function including hematopoietic, liver, renal, heart, and coagulation function as specified
You will not qualify if you...
- Allergy to human or mouse monoclonal antibodies, Zanubrutinib capsules, or their excipients
- Major surgery within 4 weeks prior to enrollment (excluding diagnostic surgery)
- Uncontrolled cardiovascular, cerebrovascular, coagulation disorders, or severe infections
- Serious diseases interfering with conventional treatment
- History of active malignant tumors except certain skin and bladder cancers with no recurrence within 3 years
- Active interstitial pneumonia
- Alcohol or drug abuse
- Active chronic hepatitis B infection or positive hepatitis C virus RNA
- Active HIV or syphilis infection
- Pregnant or lactating women
- Live vaccine administered within 4 weeks before study drug
- Continuous corticosteroid treatment above specified doses
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Swallowing disorders preventing oral medication
- Mental disorders affecting compliance or informed consent
- Investigator assessment of unsuitability for study participation
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.
1 visit (in-person)
Duration - Up to 2 years or until disease progression, intolerable toxicity, withdrawal, death, or study end.
Participants receive Zanubrutinib monotherapy as maintenance therapy.
Visits as scheduled throughout treatment period
Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yizhen Liu, M.D., Ph.D.
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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