EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to:
- determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);
- determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.
详细描述
Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •age≤65 years
- •diagnosis with mantle cell lymphoma
- •Ann Arbor stage II,III or IV
- •ECOG≤1 or if ECOG≥2 but recover after pretreatment.
排除标准
- •with centre neural system involvement
- •serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
- •HIV positive or active HBV infection or other uncontrolled systematic infection
- •clinical central nervous dysfunction
- •serious surgery within 30 days
- •pregnancy or baby nursing period or un-contracepted child bearing period woman.
研究组 & 干预措施
Cyclophosphamide
750 mg/m2 ,d5
干预措施: Cyclophosphamide (Drug)
Cytarabine
2g/m2, q12h, d1
干预措施: Cytarabine (Drug)
Dexamethasone
30 mg/d, d1-5
干预措施: Dexamethasone (Drug)
Vincristine
0.4 mg/m2, IV, d1-4
干预措施: Vincristine (Drug)
Etoposide
50 mg/m2, IV, d1-4
干预措施: Etoposide (Drug)
Doxorubicin
10 mg/m2, IV, d1-4
干预措施: Doxorubicin (Drug)
Cisplatin
100mg/ m2,IV, d1
干预措施: Cisplatin (Drug)
Rituximab
375 mg/m2 IV, d1
干预措施: Rituximab (Drug)
Thalidomide
50-150mg/d, po, d1-28
干预措施: Thalidomide (Drug)
Prednisone
0.5mg/Kg, po, qod
干预措施: Prednisone (Drug)
结局指标
主要结局
progression free survival
时间窗: up to 36 months
the time interval between diagnosis and disease progression or death or last follow-up
次要结局
- overall survival(up to 36 months)
- complete remission(up to 6 months)
研究者
Yi Shuhua
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, China