NCT01478191已完成不适用
Prognosis of Patients With Relapsed/Refractory Hl Treated With Combination of Ifosfamide, Gemcitabine and Vinorelbine(IGEV) Induction Therapy Before High-dose Chemotherapy (HDCT) With Autologous Hematopoietic Stem Cells Transplantation (AHSCT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 40
- 主要终点
- The prognostic score will be defined taking into account Overall Survival (OS).
研究概览
简要总结
This is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory HL that received IGEV scheme as induction therapy to HDCT and AHSCT for reassess the most common prognostic factors and try to identify a prognostic score with clinical and therapeutic relevance by using 6 clinical tools:
- B symptoms(yes/no)
- relapse in previously irradiated areas(yes/no)
- Ann Arbor Stage (III/IV vs I/II)
- disease status at accrual (refractory vs relapsed)
- Early relapse within 12 months of Complete Response (CR) versus late relapse after Complete Response (CR) lasting > l2 months",
- extranodal involvement (yes/no).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a history of classical HL relapsed/refractory which received IGEV regimen as induction therapy before high dose chemotherapy with AHSCT
- •Age >18 years
- •Patients with relapsed/refractory disease after standard treatments (chemotherapy +/- radiotherapy) before IGEV induction regimen. (Relapsed = disease relapse after CR.
- •Refractory = non CR with last chemotherapy line, or progression during last treatment, or disease progression within three months from previous treatment completion).
- •Availability of clinical data, laboratory values and CT scan results of patients enrolled, performed from diagnosis to the last follow-up
- •Patient scheduled to receive three or four IGEV cycles as pretransplantation induction regimen.
- •First IGEV course started before December 31st 2007
- •Assessment of tumor response by Cheson 1999 criteria 11
排除标准
- 未提供
结局指标
主要结局
The prognostic score will be defined taking into account Overall Survival (OS).
时间窗: 4 years
Surviving patents will be censored at the date of last known to be alive.
次要结局
- To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)(4 years)
研究者
研究点 (40)
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