Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- failure event free survival at 3 years
研究概览
简要总结
Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.
详细描述
All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4 cycles of (R VAD +C) .
The responders more than RP > 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.
There is an clinical and molecular evaluation of the strategy
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mantel cell lymphoma
- •At diagnosis or without anterior chemotherapy
- •Age >18 and < 66 years
- •Ann Arbor ii, III or IV
- •contraindication for rituximab treatment
- •Informed consent signed
- •No cancer anteriory
- •Renal and hepatic function compatible with the treatment
- •Ventricular Fraction > 50 % with echographic method and > 40% with isotopic method
排除标准
- •Other type of lymphoma
- •age<18 ou > 66 years
- •Informed consent not signed
- •anterior cancer
- •Contraindication to rituximab
- •Cardiac insufficiency
研究组 & 干预措施
VAD Clorambucil Rituximab
干预措施: cyclophosphamide (Drug)
VAD Clorambucil Rituximab
干预措施: Adriblastin (Drug)
VAD Clorambucil Rituximab
干预措施: dexamethasone (Drug)
VAD Clorambucil Rituximab
干预措施: Chlorambucil (Drug)
VAD Clorambucil Rituximab
干预措施: rituximab (Drug)
VAD Clorambucil Rituximab
干预措施: alkeran (Drug)
VAD Clorambucil Rituximab
干预措施: Total body irradiation (8Gy/4fr) (Procedure)
VAD Clorambucil Rituximab
干预措施: vincristine (Drug)
结局指标
主要结局
failure event free survival at 3 years
时间窗: 3 YEARS
次要结局
- Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging(8 months)
- Response rate after 4 R-(VAD+C) cycles(4 months)
- Incident of Molecular residual disease on blood, marrow and stem cell collection(3 years)
- Safety of the R-( VAD+C) regimen(8 months)
- Overall survival(3 years)