NCT01457144已完成2 期
First Line Mantle Cell Lymphoma (MCL) Treatment by RiBVD Schema in Patients Older Than 65 Years or 18 to 65 Years Old Who Cannot or Refuse Receive Conditioning Regimen Followed by Autograft
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2011年10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
- 76
- 试验地点
- 1
- 主要终点
- Improvement of progression-free survival (PFS)
研究概览
简要总结
Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.
详细描述
Demonstration of Improvement of progression-free survival (PFS) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mantle cell Lymphoma CD20 positive
- •Untreated patients
- •65 ans years old patients or 18 to 65 years old patients who can't or refuse receive conditioning regimen followed by autograft.
- •Stages Ann Arbor II, III or IV,
- •ECOG performance status of 0, 1 or 2
- •Without history of neoplasm, except in situ cervix carcinoma and cutaneous basal cell epithelioma, or in complete remission since 3 years,
- •Without drug contraindication used in the schema (Rituximab, benda-mustine, Velcade, Dexamethasone),
- •Without heart insufficiency or stabilized,
- •With the following biological values limits except if pathological values are due to Medullary invading or hypersplenism, hepatic involvement) :PNN more than 1 G/L, Platelets more than 50 G/L,Transaminases (SGOT and SGPT) and alkalin phosphatases alcalines less than 4 x normal,Bilirubin less than 3 x N,- Clearance creatinemia more than 20 mL/min
- •Hepatitis B negative serology unless the seropositivity is clearly linked to a vaccination.
- •Can be regularly followed
- •Who signed the informed consent,
- •Affiliated to a national insurance or such a same scheme .
排除标准
- •Other type of lymphoma than mantle cell lymphoma according to OMS 2008 classification
- •Patients in relapse, except those in relapse due to localized stade who only received locoregional irradiation or splenectomized,
- •Central nervous system localization in particular meninge,
- •Drug used in the schema contraindication Rituximab , Bendamustine , Velcade® or Dexamethasone
- •Non stable diabetes,
- •HIV positive or active hepatitis C or B
- •ECOG performance status equal or more than 3
- •Peripheral neuropathy, whatever its origin, rated more than 2 from NCI
- •Non stabilized heart insufficiency,
- •Patient who can't receive hyperhydration in order to treat tumoral lysis syndrome or in prophylaxis,
- •Patient who can't, whatever the reason, be regularly followed,
- •Major patient who are on legal protection, or can't give their consent
- •Patient who has not signed the informed consent
研究组 & 干预措施
RiBVD
Experimental
Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
干预措施: RiBVD (Drug)
结局指标
主要结局
Improvement of progression-free survival (PFS)
时间窗: 18 months
Improvement of progression-free survival (PFS) compared to litterature data 6 months prolongation 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen in reference with Lenz JCO 2005
次要结局
- Residual disease evaluated by molecular biology(6 years)
- Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity(6 months)
- Diagnostic PET scan results, at intermediate and final analysis(4 and 6 months)
- Overall and complete response rate after 4 cures and 6 cures(6 months)
- Intermediate response predictive factors study(4 months)
- Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index(36 months)
- Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells(42 months)
研究者
研究点 (1)
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