Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.
From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification
- •Age 16-80
- •Not previously treated
- •Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
- •Written informed consent
排除标准
- •Patients aged more than 80
- •Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
- •Psychiatric disorders
- •Uncontrolled infectious disease
- •Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function
- •Pregnancy and lactation
- •Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
结局指标
主要结局
Progression Free Survival
时间窗: 2 years
次要结局
- Interim PET positive and negative predictive value(2 years)
- Incidence of progression/relapse(2 years)
研究者
DR. ANDREA GALLAMINI
Professor
Ospedale Santa Croce-Carle Cuneo