Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma: a Phase II Multicenter Study of the Fondazione Italiana Linfomi (FIL)
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 52
- 主要终点
- To evaluate the activity of R-B combination in terms of complete response rate (CRR).
研究概览
简要总结
The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
- •Age > 70 years
- •No previous treatment
- •FRAIL patients defined as follows (see Appendices B-E) Age > 80 years with UNFIT profile, i.e.
- •ADL > 5 residual functions
- •IADL > 6 residual functions
- •CIRS 5-8 co-morbidities of grade 2
- •or Age < 80 years with
- •ADL < 4 residual functions, or
- •IADL < 5 residual functions, or
- •CIRS : 1 co-morbidity of grade 3-4, or > 8 co-morbidities of grade 2
- •Life expectancy > 6 months
- •Written informed consent
- •Accessibility of patient for treatment and follow up
排除标准
- •History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- •Previous exposure to cytotoxic agents
- •Suspect or clinical evidence of CNS involvement by lymphoma
- •HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine
- •AST /ALT > twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl
- •Evidence of any severe active acute or chronic infection
- •Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
- •Senile dementia
- •Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
研究组 & 干预措施
Bendamustine
Bendamustine is a novel chemotherapeutic agent, a hybrid of a purine analogue and an alkylator. It shows only partial in vitro cross-resistance with other alkylating agents and it is clinically well tolerated. In fact it has shown to be active in vitro against cell lines which are resistant to other alkylating agents. Preclinical data demonstrate that bendamustine acts in two distinct ways to kill cancer cells: it damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect may be attributable to its unique chemical structure.Bendamustine has demonstrated clinical activity in patients with chronic lymphocytic leukaemia, patients with relapsed indolent NHL, mantle cell lymphoma, multiple myeloma and several solid tumors.
干预措施: Bendamustine+Rituximab (Drug)
结局指标
主要结局
To evaluate the activity of R-B combination in terms of complete response rate (CRR).
时间窗: 4 years
To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.
时间窗: 4 years
次要结局
- To evaluate progression free survival (PFS)(4 years)
- To evaluate overall survival (OS)(4 years)