EUCTR2019-000413-36-IT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 - N.A.
BeiGene Ltd.0 个研究点目标入组 500 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •= 70 years of age at the time of informed consent, OR
- •65-69 years of age with comorbidities precluding autologous stem cell
- •transplantation
- •Histologically confirmed diagnosis of MCL
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
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
- •Requires ongoing treatment with a strong CYP3A inhibitor or inducer
研究者
相似试验
招募中
1 期
A study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in patients with relapsed/refractory Follicular LymphomaRelapsed/Refractory Follicular LymphomaMedDRA version: 27.0Level: PTClassification code: 10085128Term: Follicular lymphoma Class: 100000004864CTIS2024-511594-30-00Kite Pharma Inc.163
招募中
3 期
A study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in patients with relapsed/refractory Follicular Lymphoma2024-511594-30-00Kite Pharma Inc.143
进行中（未招募）
1 期
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 TransplantatioMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2019-000413-36-BEBeiGene, Ltd.500
招募中
1 期
A Study of Zanubrutinib Versus Lenalidomide in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (MAHOGANY)marginal zone lymphoma, follicular lymphomaMedDRA version: 20.0Level: SOCClassification code: 10005329Term: Blood and lymphatic system disorders Class: 3MedDRA version: 20.0Level: PTClassification code: 10076596Term: Marginal zone lymphoma Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061170Term: Follicle centre lymphoma follicular grade I II III Class: 100000004864CTIS2022-502548-12-00Beigene Ltd.863
进行中（未招募）
1 期
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 TransplantatioMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2019-000413-36-ATBeiGene, Ltd.500