Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).
The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
- •In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
- •ECOG performance status of 0-2 at study entry
- •Laboratory test results within these ranges: ANC <=1500/μL, Platelet count <= 100,000/μL. Patients with ANC <1500/μL or plt <100,000/μL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible.
- •creatinine clearance of >60 mL/min as determined by the Cockcroft-Gault calculation.
- •Total bilirubin <= 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
- •Serum transaminases AST (SGOT) and ALT (SGPT) <=5x ULN, Serum alkaline phosphatase ≤5 X ULN.
- •Disease free of prior malignancies for ≥ 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery).
- •Patients may have received prior therapy with bendamustine or lenalidomide, but must not have disease that is refractory to bendamustine or lenalidomide.
- •Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.
排除标准
- •Has received >5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
- •Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
- •Prior history or current evidence of central nervous system or leptomeningeal involvement.
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to thalidomide.
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Known to be positive for HIV or infectious hepatitis, type B or C.
研究组 & 干预措施
Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
干预措施: Bendamustine (Drug)
Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
干预措施: Rituximab (Drug)
Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
Progression-free Survival
时间窗: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
次要结局
- Overall Survival(42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up))
- Objective Response Rate (Complete + Partial Responses)(42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up))
- Toxicities Observed With Induction Chemotherapy and Maintenance Therapy(42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up))