NCT01553786已完成2 期
STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL)
The Lymphoma Academic Research Organisation30 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 30
- 主要终点
- Complete response rate
研究概览
简要总结
This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
- •Age from 60 to 80 years.
- •Eastern Cooperative Oncology Group performance status 0 to
- •No previous therapy (except corticosteroids providing they have been initiated less than 15 days before inclusion).
- •Spontaneous life expectancy > 1 month.
- •Written informed consent. The Lenalidomide Information Sheet (in appendix N of the protocol) will be given to each patient receiving lenalidomide study therapy. The patient must read this document prior to starting lenalidomide study treatment and each time they receive a new supply of study drug.
- •Male patients must:
- •Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
- •Agree to not give semen or sperm during study drug therapy and for a period after end of study drug therapy.
- •All patients must:
- •Have an understanding that the study drug could have a potential teratogenicity.
- •Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
- •Agree not to share study medication with another person.
- •Be counselled about pregnancy precautions and risks of foetal exposure.
排除标准
- •Others categories of T-cell lymphoma.
- •Central nervous system involvement by lymphoma.
- •Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days) before inclusion.
- •Contra-indication to any drug included in the CHOP regimen.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision).
- •Active bacterial, viral or fungal infection, in particular active hepatitis B or C and HIV positive serological test.
- •Impaired renal function (Creatinine clearance <50 ml/min (as calculated by the Cockcroft-Gault formula)) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
- •Poor bone marrow reserve as defined by neutrophils < 1.0 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
- •Any history of malignancy, other than that treated in this research, unless the patient has remained free of the disease for over 5 years.
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- •Hypersensitivity to the active substance or to any of the excipients.
- •Pregnant and lactating woman
- •Females of Childbearing potential (FCBP*) according to the Pregnancy Prevention Plan in appendix L of the protocol)
- •The Pregnancy Prevention Plan defines a female of childbearing potential as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
研究组 & 干预措施
lenalidomide
Experimental
lenalidomide + CHOP
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Complete response rate
时间窗: maximum 60 days after last study drug intake
次要结局
未报告次要终点
研究者
研究点 (30)
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