NCT06647732进行中（未招募）2 期
Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT): a Single-arm, Open-label, Multicenter, Phase II Study（ZAMA）
Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Complete Response(CR)
研究概览
简要总结
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.
详细描述
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:
- Rituximab: 375 mg/m², administered once a week in Cycle 1 (C1) and on Day 1 (D1) of Cycles 2-6 (C2-C6).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •An ECOG performance status score of 0-
- •An expected survival time of more than 12 months.
- •Adequate bone marrow, cardiac, pulmonary, liver, and kidney function.
- •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.
排除标准
- •Patients with a history of stroke, intracranial hemorrhage, or warfarin use within the past 6 months.
- •Patients with central nervous system involvement.
- •Patients who have undergone allogeneic hematopoietic stem cell transplantation in the past.
- •Patients who have previously used BTK inhibitors or received CD20 monoclonal antibody therapy.
- •5, Patients with active infections, except for tumor-related B-symptom fever.
- •Patients with a concurrent history of other malignancies, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
- •7. Patients receiving potent cytochrome P450 inhibitors.
- •Patients with severe cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or a history of myocardial infarction within the past 12 months.
- •9. Patients, as judged by the investigator, who have significant organ dysfunction or uncontrollable comorbidities that pose a safety risk, or who have absorption and metabolism issues with Zanubrutinib.
- •10. Pregnant or breastfeeding women and women of childbearing age unwilling to use contraception.
- •11. Patients who have received anti-tumor therapy within 4 weeks prior to enrollment.
- •12. Patients with active chronic hepatitis B or active hepatitis C.
- •Patients who have received systemic corticosteroid treatment or other immunosuppressive therapy within 14 days prior to the start of study treatment.
研究组 & 干预措施
Zanubrutinib in combination with Rituximab
Experimental
Eligible patients will receive:
- Rituximab: 375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6).
- 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.
干预措施: Zanubrutinib (Drug)
Zanubrutinib in combination with Rituximab
Experimental
Eligible patients will receive:
- Rituximab: 375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6).
- 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.
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete Response(CR)
时间窗: Up to 8 cycles (each cycle is 28 days)
Defined as the proportion of patients who achieve complete remission as the best response
次要结局
- Objective response rate(ORR)(Up to 8 cycles (each cycle is 28 days))
- 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)
- 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)
- Overall survival(OS)(From the date of enrollment until the date of death from ant cause, assessed up to 24 months)
- 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)
- 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)
研究者
Qingqing Cai
chief physician
Sun Yat-sen University
研究点 (2)
Loading locations...
相似试验
招募中
2 期
Rituximab and Zanubrutinib in Patients With Indolent B-cell LymphomasB-Cell LymphomaMarginal Zone LymphomaFollicular LymphomaNCT06350318H. Lee Moffitt Cancer Center and Research Institute43
招募中
2 期
Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell LymphomaMantle Cell LymphomaNCT05635162University College, London50
招募中
2 期
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell LymphomaRefractory or Relapsed Diffuse Large B Cell LymphomaNCT06554600Second Affiliated Hospital, School of Medicine, Zhejiang University36
Unknown
2 期
Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical TrialOverall SurvivalNCT05392257Qingdao Central Hospital20
招募中
2 期
Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCTPCNSLNCT05896007Ruijin Hospital29