NCT05051891招募中3 期
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 22
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
- •Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
- •No previous systemic treatment for MCL.
- •ECOG physical strength score is 0-
- •Expected survival time >6 months.
- •Voluntary written informed consent prior to screening.
排除标准
- •Uncontrolled or significant cardiovascular diseases
- •History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
- •Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
- •Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
- •Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
the experimental group
Experimental
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
干预措施: Orelabrutinib and R-CHOP (Drug)
The control group
Experimental
R-CHOP
干预措施: R-CHOP (Drug)
结局指标
主要结局
PFS
时间窗: Up to 6 years
To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).
次要结局
- OS(Up to 6 years)
- ORR(Up to 6 years)
- CRR(Up to 6 years)
研究者
研究点 (22)
Loading locations...
相似试验
招募中
3 期
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT05234684Beijing InnoCare Pharma Tech Co., Ltd.150
招募中
2 期
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCLDiffuse Large B-Cell LymphomaNCT05498259The First Affiliated Hospital of Soochow University46
招募中
2 期
Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System InvolvementCNS LymphomaNCT05926427Ruijin Hospital25
招募中
2 期
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）Diffuse Large B Cell Lymphoma (DLBCL)NCT06647940Sun Yat-sen University39
招募中
不适用
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local TherapyMarginal Zone LymphomaNCT06478472The First Affiliated Hospital of Xiamen University36