Lenalidomide Combined With R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- 2-year progression free survival
研究概览
简要总结
In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)
详细描述
Double expressor lymphoma is a subtype of diffuse large B-cell lymphoma defined as having increased expression of MYC and BCL-2 by immunohistochemistry. Patients with double-expressor lymphomas have a poor prognosis when treated with standard chemoimmunotherapy and have increased risk of progression and recurrence. The investigators conducted this study to evaluate the efficacy of lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Lenalidomide is the second-generation immunomodulatory drug, and its anti-tumor mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this kind of disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-75 years old
- •Eastern Cooperative Oncology Group performance status 0 to 2;
- •Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, and Myc≥40% as well as Bcl-2≥50% through immunohistochemistry；
- •Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥1.0cm in short-diameter by CT or MRI.
- •White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L. If abnormal factors of peripheral blood caused by bone marrow or spleen involvement of lymphoma, whether to enroll depends on the judgment of researchers
- •Total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN
- •serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 40 ml/min
- •Ultrasonic cardiogram or nuclide cardiac function showed left ventricle ejection fraction ≥ 50%
- •Women of childbearing potential and men who are sexually active are consent to practicing a highly effective method of birth control. Women of childbearing potential must have a negative serum β-hCG within 2 weeks of enrollment
- •Patients have written informed consent to participate in the study.
排除标准
- •Prior sever allergy to humanized or mouse derived monoclonal antibody. Unable to receive either lenalidomide or R-CHOP background chemotherapy.
- •History of myocardial diseases, such as unstable angina pectoris, acute myocardial infarction within 6 months of enrollment, congenital heart failure NYHA III/IV
- •Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, EBV positive DLBCL, primary cutaneous large B lymphoma, leg type.
- •Presence of CNS involvement
- •Having surgeries ≥ grade 2 within 3 weeks of enrollment.
- •History or now in the treatment process of other malignancies except cured basal cell carcinoma of skin (melanoma not included), and carcinoma in-situ of uterine cervix.
- •More than grade 3 neurotoxicity within 2 two weeks of enrollment
- •Receiving any treatment for lymphoma except short use of corticosteroid (no more than 10 days)
- •History of deep vein thrombosis or pulmonary embolism within 12 months of enrollment
- •Unable or reject to receive antithrombotic treatment
- •Presence of active HBV infection (HBsAg positive and HBV-DNA≥ 104), HCV infection, acquired and congenital immunodeficiency diseases include but not limited to HIV
- •Pregnant or lactating women
- •Previously received organ transplant
- •Serious uncontrolled infection
- •Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.
- •Severe neurol of mental illness, including dementia and epilepsy.
- •Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results
- •Patients considered unsuitable to participate in the study by the researchers
研究组 & 干预措施
R2-CHOP
Lenalidomide combined with rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone
干预措施: Lenalidomide combined with R-CHOP (Drug)
结局指标
主要结局
2-year progression free survival
时间窗: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
次要结局
- Hematology and non hematology toxicity(Throughout the treatment period，up to 6 months)
- objective response rate(at the end of Cycle 6 (each cycle is 21 days))
- overall survival(From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years)
研究者
Junning Cao, MD
Principal Investigator
Fudan University