NCT06760039招募中1 期
Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study
Sun Yat-sen University10 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- 2-year event-free survival (EFS) rate assessed by the independent review committee
研究概览
简要总结
This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18,≤80 years, both male and female.
- •Pathologically confirmed DLBCL
- •No prior treatment for DLBCL.
- •There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Expected survival ≥3 months.
- •International Prognostic Index (IPI) ≤ 2
- •Sufficient bone marrow, liver, and kidney function.
排除标准
- •Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
- •Transformed DLBCL.
- •Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
- •The patients had previously received antitumor therapy.
- •Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- •Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
- •Mentally ill persons or persons unable to obtain informed consent.
- •The investigators think that the patient is not suitable for the study.
研究组 & 干预措施
Experimental group
Experimental
R-CMOP group
干预措施: R-CMOP Regimen (Drug)
Control group
Active Comparator
R-CHOP group
干预措施: R-CHOP Regimen (Drug)
结局指标
主要结局
2-year event-free survival (EFS) rate assessed by the independent review committee
时间窗: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
To investigate the antitumor efficacy
RP2D(Phase Ib)
时间窗: Cycle 1 in R-CMOP group (28 days)
Phase II Recommended Dose
DLT(Phase Ib)
时间窗: Cycle 1 in R-CMOP group (28 days)
Dose-limiting toxicity
次要结局
- AE and SAE (Phase Ib)(Up to 24 weeks)
- 2-year event-free survival (EFS) rate assessed by the investigators(Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.)
- 2-year Overall survival(OS)(Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment)
- 2-year Progression-free survival(PFS)(Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment)
- Objective response rate (ORR)(Up to 24 weeks)
- Complete response rate (CRR)(Up to 24 weeks)
研究者
Qingqing Cai
Professor
Sun Yat-sen University
研究点 (10)
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