NCT07199296招募中2 期
A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
- •Age > 14 years of age, both genders are eligible.
- •Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
- •At least one measurable lesion.
- •Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10^9/L, absolute neutrophil count ≥1.5×10^9/L, hemoglobin ≥90g/L, platelet count ≥75×10^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.
- •The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.
- •Willing and able to participate in all required assessments and procedures of the study protocol.
排除标准
- •Patients who have previously received treatment with BTK inhibitors.
- •Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 > 30%, TP53 abnormality, blastic or pleomorphic variation.
- •Patients with severe complications or serious infections.
- •Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- •Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- •HIV-infected individuals.
- •Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
- •Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
研究组 & 干预措施
Experimental: Orelabrutinib + Rituximab +/- ASCT and Orelabrutinib Maintenance
Experimental
- In induction phase, patients will receive rituximab 375 mg/m² IV on day 1,8,15,22 in Cycle 1, then day 1/cycle, and orelabrutinib 150 mg/day PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation.
- ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2.
- In maintenance phase, patients will recieve orelabrutinib 150 mg/day PO once daily until disease progression or intolerable toxicity.
干预措施: Orelabrutinib (Drug)
Experimental: Orelabrutinib + Rituximab +/- ASCT and Orelabrutinib Maintenance
Experimental
- In induction phase, patients will receive rituximab 375 mg/m² IV on day 1,8,15,22 in Cycle 1, then day 1/cycle, and orelabrutinib 150 mg/day PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation.
- ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2.
- In maintenance phase, patients will recieve orelabrutinib 150 mg/day PO once daily until disease progression or intolerable toxicity.
干预措施: Rituximab (R) (Drug)
Experimental: Orelabrutinib + Rituximab +/- ASCT and Orelabrutinib Maintenance
Experimental
- In induction phase, patients will receive rituximab 375 mg/m² IV on day 1,8,15,22 in Cycle 1, then day 1/cycle, and orelabrutinib 150 mg/day PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation.
- ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2.
- In maintenance phase, patients will recieve orelabrutinib 150 mg/day PO once daily until disease progression or intolerable toxicity.
干预措施: BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) (Drug)
Experimental: Orelabrutinib + Rituximab +/- ASCT and Orelabrutinib Maintenance
Experimental
- In induction phase, patients will receive rituximab 375 mg/m² IV on day 1,8,15,22 in Cycle 1, then day 1/cycle, and orelabrutinib 150 mg/day PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation.
- ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2.
- In maintenance phase, patients will recieve orelabrutinib 150 mg/day PO once daily until disease progression or intolerable toxicity.
干预措施: orelabrutinib maintenance (Drug)
结局指标
主要结局
Complete response rate
时间窗: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
次要结局
- Overall Response Rate(End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
- Progression-free survival(Baseline up to data cut-off (up to approximately 3 years))
- Overall survival(Baseline up to data cut-off (up to approximately 3 years))
研究者
研究点 (1)
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