A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fully understand and voluntarily participate in this study and sign informed consent
- •Age≥18 years old
- •International Prognostic Index (IPI)>2
- •Expected survival ≥ 3 months
- •DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype
- •Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment
- •At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion: Greatest transverse diameter>1.5cm; Extra-nodal lesion: Greatest transverse diameter>1.0cm
- •ECOG Performance Status: 0-1
- •Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group)
- •Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases).
排除标准
- •Hypersensitivity to any study drug or its components
- •Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
- •Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac ejection fraction (LVEF)< 45%
- •Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal)
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive)
- •Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years)
- •Subjects suffering from primary or secondary central nervous system (CNS) lymphoma
- •pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures
- •Mental patients or those who cannot obtain informed consent
- •Unsuitable subjects for this study determined by the investigator.
研究组 & 干预措施
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
干预措施: Mitoxantrone hydrochloride liposome injection (Drug)
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
干预措施: RiTUXimab Injection (Drug)
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
干预措施: Cyclophosphamid (Drug)
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
干预措施: Vincristine (Drug)
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
干预措施: Prednisolone (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
To evaluate the efficacy of anti-tumor
次要结局
- Duration of Response (DOR)(CR or PR up to data cut-off (up to approximately 2 years))
- Complete response rate (CRR)(At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days))
- Progression-free survival (PFS)(Baseline up to data cut-off (up to approximately 2 years))
- Overall survival (OS)(Baseline up to data cut-off (up to approximately 2 years))
- Treatment emergent adverse events (TEAEs)(The first dose up to 21 or 28 days after the last dose)
研究者
Ou Bai, MD/PHD
Director
The First Hospital of Jilin University