NCT03795571Unknown1 期
Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- maximum tolerated dose and dose limited toxicity
研究概览
简要总结
Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and Refractory DLBCL.The investigators therefore design this phase I study to investigate the safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old;
- •ECOG PS 0- 2;
- •Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma),relapse or refractory,defined as:
- •relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like)
- •SD as best response after 4 cycles or PD after 2 cycles of first-line immunochemotherapy;
- •a measurable or evaluable disease at the time of enrollment(diameter ≥ 1.5cm）；
- •Eligible for subsequent autologous stem cell transplantation；
- •Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
- •Expected survival ≥ 12 weeks；
- •Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures；
- •Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons；
- •Used of systemic anti-tumor treatment within four weeks；
- •CNS or meningeal involvement;
- •Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr< 50 mL/min unless these abnormalities were related to the lymphoma;
- •Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- •New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia；
- •Known sensitivity or allergy to investigational Product;
- •Major surgery within three weeks;
- •Presence of Grade III nervous toxicity within past two weeks;
- •Active and severe infectious diseases;
- •History of DVT or PE within past 12 months；
- •Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
- •In any conditions which investigator considered ineligible for this study.
研究组 & 干预措施
R2-GOD
Experimental
干预措施: Rituximab (Drug)
R2-GOD
Experimental
干预措施: Gemcitabine (Drug)
R2-GOD
Experimental
干预措施: Oxaliplatin (Drug)
R2-GOD
Experimental
干预措施: Dexamethasone (Drug)
R2-GOD
Experimental
干预措施: Lenalidomide Oral Capsule (Drug)
结局指标
主要结局
maximum tolerated dose and dose limited toxicity
时间窗: 28 days after first cycle of R2-GOD regimen
次要结局
- Overall response rate,(6 months)
- Progressive free survival(2 years)
- Overall survival(2 years)
研究者
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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