NCT06151080招募中2 期
An Open, Single-arm Clinical Study of Lenalidomide Combined With G-CHOP(LO-CHOP) in the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With Follicular Lymphoma (CDLBCL-FL).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
To evaluate the efficacy and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
详细描述
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Complete response, Overall Survival, Progression Free Survival) and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old, gender is not limited;
- •According to the REAL/WHO classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (CDLBCL-FL): the same lymph node specimen showed diffuse large b-cell lymphoma and follicular lymphoma, or the tissue specimen showed diffuse large b-cell lymphoma and indolent lymphoma in bone marrow pathology; or the different group specimens suggested diffuse large b-cell lymphoma and/or follicular lymphoma, respectively, with stage II-IV.
- •Using the Lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: PET/CT can evaluate the lesion, CT or MRI can evaluate the lesion in the node with a diameter greater than 1.5 cm, a short diameter greater than 1.0 cm, or an extranodal lesion with a diameter greater than or equal to 1.0 cm
- •Left ventricular ejection fraction (LVEF) was less than 45%
- •HBV-positive serology (occult carriers: anti-HBeAg +, anti-HBsAg-, anti-HBsAg +/-) can only be enrolled if the HBV-dna test is negative.
- •Normal major organ function: liver function: serum bilirubin ≤2.0 × ULN, serum ALT and AST ≤2.5 × ULN, renal function: serum CR ≤2.0 × ULN; (unless caused by lymphoma)
- •Absolute neutrophil count (ANC)≥1.0 × 109 l, platelet count (PLT)≥100 × 109 L, hemoglobin content (HGB)≥80 g L, if myeloma was involved, ANC ≥0.75 × 109 L, platelet count (PLT)≥50 × 109 L, HGB content (HGB) was not required.
- •Life expectancy ≥6 months
- •Informed consent (all studies had to sign a patient's informed consent form)
排除标准
- •DLBCL of primary and secondary centers;
- •HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing)
- •Clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure>115 mmHG), uncontrolled arrhythmias, symptomatic angina pectoris, or NYHA III-IV congestive heart failure.
- •Severe chronic obstructive pulmonary disease complicated with hypoxemia.
- •Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy
- •Except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early breast cancer only requires surgery. Other malignant tumors have occurred within the past 3 years or at the same time
研究组 & 干预措施
LO-CHOP
Experimental
Lenalidomide combined with G-CHOP
干预措施: Lenalidomide combined with G-CHOP (LO CHOP) (Drug)
结局指标
主要结局
Complete remission rate
时间窗: Up to 28 months
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
次要结局
- Progression-free survival(From the randomization until the first documentation of PD or death whichever occurs first or up to 28 months)
- Overall survival(Up to 28 months)
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University
研究点 (1)
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