A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.
详细描述
ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
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
- •primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
- •more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
- •estimated survival >/3months
- •Age 18-65 years
- •Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
- •Signature of informed consent
排除标准
- •Age <\ 18years
- •without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
- •without measurable lesions
- •being treated by other drugs in other clinical trials
- •Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
- •Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
- •Renal insufficiency: more than 2 times higher than that of normal serum creatinine
- •Blood screening period: WBC < 1 * 109/L * 109/L; platelet < 25; Hb < 60g/L
- •HIV test positive
研究组 & 干预措施
crizotinib combined with chemotherapy
crizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
干预措施: crizotinib (Drug)
结局指标
主要结局
complete remission rate
时间窗: 2 years
次要结局
- objective response rate(2 years)
- incidence of >/Grade 3 non-hematology toxicity adverse events(2 years)
- QOL assessment(2 years)
- disease-free survival(2 years)
- overall survival(2 years)
研究者
Jun Zhu
Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary
Peking University