Zanubrutinib Plus Rituximab As Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
- Conditions
- Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
- Interventions
- Registration Number
- NCT06647732
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib in combination with Rituximab Zanubrutinib 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. Zanubrutinib in combination with Rituximab 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.
- Primary Outcome Measures
Name Time Method Complete Response(CR) Up to 8 cycles (each cycle is 28 days) Defined as the proportion of patients who achieve complete remission as the best response
- Secondary Outcome Measures
Name Time Method Time to Response(TTR) 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 To investigate the preliminary anti-tumor efficacy
Objective response rate(ORR) Up to 8 cycles (each cycle is 28 days) The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Progression-free survival(PFS) 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 To investigate the preliminary anti-tumor efficacy
Event-free survival(EFS) The proportion of patients without disease progression, treatment discontinuation, or death for any reason since enrollment, assessed up to 24 months To investigate the preliminary anti-tumor efficacy
Overall survival(OS) From the date of enrollment until the date of death from ant cause, assessed up to 24 months To investigate the preliminary anti-tumor efficacy
Duration of Response(DOR) The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months To investigate the preliminary anti-tumor efficacy
Trial Locations
- Locations (1)
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China