NCT04432714招募中1 期
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年6月9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
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- maximum tolerated dose and dose limited toxicity
研究概览
简要总结
The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.
- •ECOG PS 0-2
- •Age 18-60 years old
- •Expected survival ≥ 12 weeks
- •A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
- •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
- •Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
- •Previous exposure to any anti-tumor therapy
- •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
- •History of DVT or PE within past 12 months
- •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
- •CNS or meningeal involvement
- •Known sensitivity or allergy to investigational product
- •Major surgery within three weeks
- •Patients receiving organ transplantation
- •Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
- •Presence of Grade III nervous toxicity within past two weeks
- •Active and severe infectious diseases
- •Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
- •In any conditions which investigator considered ineligible for this study
- •Patients with histological transformation.
研究组 & 干预措施
R2-DA-EPOCH
Experimental
干预措施: Lenalidomide (Drug)
R2-DA-EPOCH
Experimental
干预措施: Rituximab (Drug)
R2-DA-EPOCH
Experimental
干预措施: Etoposide (Drug)
R2-DA-EPOCH
Experimental
干预措施: Doxorubicin (Drug)
R2-DA-EPOCH
Experimental
干预措施: Vincristine (Drug)
R2-DA-EPOCH
Experimental
干预措施: Cyclophosphamide (Drug)
R2-DA-EPOCH
Experimental
干预措施: Prednisone (Drug)
结局指标
主要结局
maximum tolerated dose and dose limited toxicity
时间窗: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)
Overall response rate
时间窗: 6 months
次要结局
- 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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