NCT01195766已完成2 期
Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea14 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 14
- 主要终点
- Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
研究概览
简要总结
The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.
In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.
详细描述
In addition to the above:
- To asses the complete response rate after O-ESHAP.
- To asses the toxicity of O-ESHAP regimen
- To asses the stem cells mobilization capacity of O-ESHAP regimen
- To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)
- To investigate the correlation between the overall response and CD20 expression by tumoral cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.
- •Age 18 to 65 years. Patient >65 and <70 years old with ECOG < 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.
- •Leucocytes > 3,0 x 109/L and platelets > 100 x 109/L.
- •No major organ dysfunction.
- •Written informed consent.
- •HIV negative.
- •No active hepatitis B or C infection.
- •Availability of histological report of biopsy at diagnosis or at relapse and availability of biopsy to be revised by reference pathologists.
- •Absence of other neoplasia, except basocellular tumor or carcinoma of the uterine cervix in situ.
- •Contraception measures in fertile females.
排除标准
- •Subjects who have current active hepatic or biliary disease
- •presence of pathology that would contraindicate the administration of chemotherapy
- •HIV positive
- •Hepatitis B or C infection
- •history of other malignancies in addition to those specified in the inclusion criteria
- •informed consent not signed
- •Pregnant and / or breast-feeding or reproductive capacity adults who do not use an effective method of birth control during study treatment and at least six months later. An effective method is that used at least one barrier mechanism.
研究组 & 干预措施
Ofatumumab
Experimental
Ofatumumab in addition to ESHAP therapy
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
时间窗: 4 years follow-up
次要结局
- To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary(4 years follow-up)
研究者
研究点 (14)
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