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.
The purpose of this study is 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. Treatrment: 1. Rituximab: 375 mg/m², administered once a week in 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. Patients with partial remission (PR) or stable disease (SD) will receive 2 additional cycles. The primary study endpoint is the complete remission rate of Zanubrutinib in combination with Rituximab in the treatment of newly diagnosed mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
160 mg, administered twice daily from Day 1 to Day 28 (D1-D28)
375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6)
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Complete Response(CR)
Defined as the proportion of patients who achieve complete remission as the best response
Time frame: Up to 8 cycles (each cycle is 28 days)
Objective response rate(ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Time frame: Up to 8 cycles (each cycle is 28 days)
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Event-free survival(EFS)
To investigate the preliminary anti-tumor efficacy
Time frame: The proportion of patients without disease progression, treatment discontinuation, or death for any reason since enrollment, assessed up to 24 months
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months
Time to Response(TTR)
To investigate the preliminary anti-tumor efficacy
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Time frame: The time from the start of patient enrollment in the trial to the first efficacy assessment achieving CR or PR, assessed up tp 24 months