Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.
详细描述
study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications.
patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points.
Early Interim PET will be carried out Further therapy will be based on the study results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin lymphoma patients
- •age 18-60 for those with early disease and advanced disease with score less then 3
- •age 18-60 years for patients with advanced disease score 3 or higher classical Hodgkin lymphoma
- •WBC more then 3500
- •platelets more then 100000
- •creatinin less then 2.0 mg
- •bilirubin less then 2.0 mg
- •absolute neutrophil count more then 1000 unless bone marrow involvement If marrow involve, patient with lower count but ANC of 1000 may be included.
排除标准
- •Positive serology for HIV
- •bilirubin more then 2 mg/dl
- •creatinin more then 2 mg/dl
- •lactating woman or pregnant
- •patient older then 60 years with high risk disease of score 3 or more
研究组 & 干预措施
Early favorable
patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD
干预措施: PET/CT post 2 cycles of chemotherapy (Other)
Early Unfavorable
Patients with early favorable disease Ia or IIa with risk factors :large mediastinal mass extra nodal disease elevated esr, three or more involved areas, age equal or >50 , lymphocytic depleted or mixed cellularity
干预措施: PET/CT post 2 cycles of chemotherapy (Other)
advanced disease
patients with advanced disease low IPS score 0-2 will start chemotherapy with ABVD for 2 cycles followed by PET/CT further therapy will be given according to PET/CT results
干预措施: PET/CT post 2 cycles of chemotherapy (Other)
advanced disease IPS 3-7
Patients with advanced disease IPS score 3-7 will start chemotherapy with escalated beacopp. following 2 cycles PET/CT will be carried out and according to results further chemotherapy will be given
干预措施: PET/CT post 2 cycles of chemotherapy (Other)
结局指标
主要结局
Event Free Survival
时间窗: 5 years
Event Free survival in various risk groups of patients
时间窗: five years
次要结局
- overall survival5 years(5 years)
- event free survival 5 years(five years)
- Disease free survival 5 years(five years)
研究者
e_dann
Eldad J Dann assoc Prof of Hematology (Clinical), director of blood bank and aphaeresis unit RAMBAM health care campus Haifa Israel
Rambam Health Care Campus