Phase II Study With Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Before High Dose Chemotherapy With Autologous Hematopoietic Stem Cells Transplant
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects
详细描述
The aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (BeGEV) scheme efficacy as induction therapy to high dose chemotherapy with Allogeneic Hematopoietic Stem-Cell Transplantation (AHSCT) for patients with relapsed/refractory Hodglin's Lymphoma (HL).
Four BeGEV courses repeated every 3 weeks in the absence of any reasons listed in the paragraph 7.5; whenever an objective response is observed at disease evaluation performed after IV cycle patients undergo to high dose chemotherapy with AHSCT (conditioning regimens based on preference of each Centre).
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
- •relapsed/refractory disease after receiving one line of standard chemotherapy
- •history of classical Hodgkin's Lymphoma (HL)
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •at least one site of measurable nodal disease at baseline ≥ 1.5 cm
- •Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L
排除标准
- •Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL)
- •prior radiation therapy ≤ 3 weeks prior to start of study treatment
- •any concurrent anti-cancer therapy
- •evidence of another malignancy not in remission or history of such a malignancy within the last 2 years.
- •aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement
- •known history of Human immunodeficiency virus (HIV)seropositivity
- •hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis
研究组 & 干预措施
BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
干预措施: Bendamustine (Drug)
BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
干预措施: Gemcitabine (Drug)
BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Response Rate
时间窗: 3 months
response rate after BeGEV in terms of Complete Response (CR)evaluated by fludeoxyglucose Positron emission tomography (FDG-PET) and Computed Tomography (CT-scan) after four cycles.
次要结局
- overall response rate(3 months)
- Progression free survival (PFS), Overall Survival (OS).(2 years)
- mobilization potential of the combination(3 months)
- toxicity of the combination(3 months)
研究者
Armando Santoro, MD
MD
Istituto Clinico Humanitas