Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To assess the feasibility of Revlimid as salvage treatment in PTCL
研究概览
简要总结
Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologic diagnosis of PTCL according to the WHO-REAL classification;
- •Age > 18 years;
- •Relapsed (³1) or refractory to conventional chemotherapy/radiotherapy;
- •Stage I-IV according to the Ann Arbor staging System;
- •Performance status <2;
- •Adequate bone marrow reserve: platelets >50 x 10(9)/L, absolute neutrophil count
- •(ANC) > 1.0 x 10(9)/L, hemoglobin >8 g/d;
- •Normal renal and hepatic functions;
- •Negative HIV, HCV, and HBV status;
- •Informed consent prior to registration on study
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to thalidomide.
- •The development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Any prior use of lenalidomide.
- •Concurrent use of other anti-cancer agents or treatments.
- •Known positive for HIV or infectious hepatitis, type A, B or C.
研究组 & 干预措施
Revlimid
Oral Revlimid is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.
After this induction phase, the CR, PR and SD will continue Revlimid with the same schedule for other 8 months.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
To assess the feasibility of Revlimid as salvage treatment in PTCL
时间窗: 12 months
次要结局
- To assess the overall response rate (CR and PR) of PTCL receiving REVLIMID; To assess the Tumor Control Rate (TCR); To assess the duration of response; To assess the quality of life.(12 months)
研究者
Pier Luigi Zinzani
Professor
University of Bologna