Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 264
- 试验地点
- 39
- 主要终点
- Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
研究概览
简要总结
PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.
详细描述
This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients confirmed Hodgkin's lymphoma at refractory at first line therapy, relapse early or late;
- •Age > 18 years;
- •Life expectancy > 3 months;
- •Cardiac, pulmonary, renal and liver functions with normal range;
- •Written informed consent.
排除标准
- •Any psychological, familiar or geographical conditions that could potentially hinder the compliance to the protocol;
- •renal failure as creatinine> 1.2 mg/dl or creatinine clearance <60 ml/min;
- •AST/ALT or bilirubin> 2.5 times the norm;
- •HCV positivity with signs of ongoing viral replication (HCV PCR + AST>1.5-2x normal);
- •Heart disease clinically significant: eg. severe hypertension not controlled, multifocal uncontrolled cardiac arrhythmias, symptomatic ischemic heart disease or congestive heart failure class NYHA class III-IV (Annex 2), previous acute myocardial infarction;
- •Ventricular ejection fraction <45%;
- •decompensated diabetes mellitus not controlled by insulin therapy; Disease with significant pulmonary function defined as FEV1 <65% of predicted or DLCO <50% of predicted value;
- •HIV positive patients;
- •Patients with uncontrolled infection;
- •Neoplasia in the last 3 years except carcinoma in situ uterus, neck and basal skin cancer or prostate cancer in early stage localized exeresi treated with surgery or brachytherapy with curative intent, a good prognosis DCIS breast treated with surgery alone;
- •Drug addiction or alcoholism.
结局指标
主要结局
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
时间窗: 3 years
Patients with positive PET after salvage therapy. Evaluate the role of allogeneic transplantation in these patients after salvage chemotherapy and compare the results with those obtained by 2 cycles of high dose chemotherapy with stem cell
时间窗: 3 years
次要结局
- Evaluate the percentage of complete remission.(3 years)
- Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).(3 years)
- Evaluation of the chimera.(3 years)