Zanubrutinib Plus Rituximab As Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT): a Single-arm, Open-label, Multicenter, Phase II Study（ZAMA）
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line treatment for patients with mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma confirmed by histopathology.
• Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment .
• No prior systemic anti-lymphoma therapy (except for H. pylori eradication therapy in H. pylori-positive gastric MALT patients).
• No histopathological transformation to high-grade lymphoma.
• At least one measurable lesion according to the Lugano 2014 criteria.
⁃ 7\. Age ≥ 18 years, with no gender restrictions. 7. An ECOG performance status score of 0-2. 8. An expected survival time of more than 12 months. 9. Adequate bone marrow, cardiac, pulmonary, liver, and kidney function. 10. Willing to participate in the clinical study; fully informed and aware of the study, having signed the informed consent form; willing and able to comply with all study procedures.
Locations
Other Locations
China
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qingqing Cai, MD. PhD.
caiqq@sysucc.org.cn
02087342823
Time Frame
Start Date:2024-10-30
Estimated Completion Date:2028-09-30
Participants
Target number of participants:42
Treatments
Experimental: Zanubrutinib in combination with Rituximab
Eligible patients will receive:~1. Rituximab: 375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6).~2. Zanubrutinib: 160 mg, administered twice daily from Day 1 to Day 28 (D1-D28). Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) will end treatment and enter observation follow-up, while patients with partial remission (PR) or stable disease (SD) will receive an additional 2 cycles.
Collaborators: Shenzhen People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fifth Affiliated Hospital of Guangzhou Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University, Beijing Tongren Hospital, Gansu Cancer Hospital, Tongji Medical College of Huazhong University of Science & Technology