Multicenter Clinical Study With Early Treatment Intensification In Patients With High- Risk Hodgkin Lymphoma, Identified As FDG-PET Scan Positive After 2 Conventional ABVD Courses
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 450
- 试验地点
- 24
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy.
详细描述
Version number 1.0 Date 07.05.0808
Study Title
A phase-II clinical trial for assessing the clinical impact of a global strategy utilizing early FDG-PET imaging for a risk-adapted therapy in untreated, advanced Hodgkin Lymphoma (aHL).
Short study title PET-adapted chemotherapy in advanced HL
Start and end dates of study Start date: July 2008
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
- •Aged 18-60
- •Not previously treated
- •Stages IIB to IV B
- •All IPS prognostic groups
- •Patients who have signed an informed consent form
排除标准
- •Patients aged more than
- •Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin's lymphoma.
- •Psychiatric disorders
- •Uncontrolled infectious disease
- •Impaired cardiac (EF < 50%) , renal (creatinine clearance < 60 ml/m)
- •HIV, HBV DNA, HCV RNA positive markers
- •Pregnancy and lactation
- •Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
研究组 & 干预措施
PET pos
Patients With Interim Pet Positive Proceed To Escalated Beacopp Regimen
干预措施: ESCALATED BEACOPP (Drug)
PET negative
Patients With Interim-Pet Negative Continue The Conventional ABVD Regimen
干预措施: CONVENTIONAL ABVD (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 3 year
次要结局
- event-free survival (EFS)(3 year)
研究者
DR. ANDREA GALLAMINI
HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE
Ospedale Santa Croce-Carle Cuneo