NCT04423926招募中1 期
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2020年6月10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
- 91
- 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 PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.
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
- •Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria.
- •ECOG PS 0-2
- •Age 18-70 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.
- •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
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
- •Patients known to have varicella or herpes zoster virus infection
- •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.
研究组 & 干预措施
Lenalidomide+CHOP
Experimental
干预措施: Lenalidomide (Drug)
Lenalidomide+CHOP
Experimental
干预措施: Cyclophosphamide (Drug)
Lenalidomide+CHOP
Experimental
干预措施: Doxorubicin (Drug)
Lenalidomide+CHOP
Experimental
干预措施: Vincristine (Drug)
Lenalidomide+CHOP
Experimental
干预措施: Prednisolone (Drug)
结局指标
主要结局
maximum tolerated dose and dose limited toxicity
时间窗: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
Overall response rate
时间窗: 6 months
overall response rate after treated by lenalidomide-CHOP regimen
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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