EUCTR2019-000413-36-BE进行中（未招募）1 期
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •= 70 years of age at the time of informed consent, OR
- •60 and < 70 years of age with comorbidities precluding autologous stem cell transplantation
- •Histologically confirmed diagnosis of MCL based on the World Health Organization 2016 classification of tumors of hematopoietic and lymphoid tissue
- •No prior systemic treatments for MCL
- •Measurable disease by CT/MRI
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate marrow and organ function
- •Please refer to the protocol for a full list of the inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 475
排除标准
- •Known central nervous system involvement by lymphoma
- •Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
- •Clinically significant cardiovascular disease
- •History of severe bleeding disorder
- •Unable to swallow capsules or disease significantly affecting gastrointestinal function
- •Active fungal, bacterial and/or viral infection requiring systemic therapy
- •Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- •Please refer to the protocol for a full list of the exclusion criteria.
研究者
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