Study of Bendamustine, Gemcitabine and Vinorelbine (BEGEV) Chemotherapeutic Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma.
Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year
详细描述
Patients with primary refractory and relapsed classical Hodgkin lymphoma attended the medical oncology department at the National Cancer Institute, Cairo University, Egypt during the period from April, 2024 to October, 2024 were randomly assigned in the 2 treatment groups using online random number generator.
Exclusion criteria include age less than 18 year, Eastern Cooperative Oncology Group(ECOG) performance status less than 2, pregnancy, second cancers chronic kidney disease, end stage renal disease, liver cell failure, HIV, HCV, HBV, and autoimmune diseases.
The basic, epidemiological, clinical, laboratory, pathological, and radiological data, and complete staging was recorded at the baseline.
The BEGEV regimen was administered as follows: gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4, vinorelbine 20 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 2 and 3.
The GDP regimen was administered as follows: Gemcitabine 1000 mg/m2 days 1 and 8, dexamethasone 20 mg/m2 days 1-4 and days 11-14 and cisplatin 25 mg/m2 days 1-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary refractory classical Hodgkin lymphoma Relapsed classical Hodgkin lymphoma Age 18 years old or more Both genders Eligible to receive the chemotherapeutic protocol.
排除标准
- •Eastern Cooperative Oncology Group(ECOG) performance status less than
- •Pregnancy. Second cancers. Chronic kidney disease End stage renal disease Liver cell failure HIV HCV HBV Autoimmune diseases
研究组 & 干预措施
BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine)
Received the BEGEV protocol
干预措施: BEGEV (Bendamustine, Gemcitabine,Vinorelbine) (Combination Product)
GDP arm (Gemcitabine,Dexamethasone,Cisplatin)
Received the GDP protocol
干预措施: GDP(Gemcitabine, Dexamethasone and Cisplatin) (Combination Product)
结局指标
主要结局
Overall response rate
时间窗: Six months
According to the International Workshop for Response Criteria for non-Hodgkin lymphomas. The response is classified as either complete response (CR), partial response (PR), stable disease(SD) or progressive disease (PD). The sum of CR and PR is labelled as overall response rate.
次要结局
- Progression free survival(20 months)
- Disease free survival(20 months)
研究者
Amgad Shaheen
Assistant professor
Cairo University