NCT01300156Unknown2 期
A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Overall Response rate to ESHAOx chemotherapy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL).
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
- •Previously histologically confirmed Hodgkin's lymphoma
- •Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
- •Performance status (ECOG) ≤ 3
- •Age ≤ 75 years old
- •Number of prior chemotherapies: one or two regimens
- •At least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
- •Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul, transaminases < 3 X upper normal values; bilirubin < 2 mg/dL
- •Written informed consent approved by institutional review board or ethic committee
排除标准
- •Previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation
- •Previous chemotherapies with ESHAP regimen
- •Any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix
- •Other serious illness or medical conditions
- •Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurologic or psychiatric disorders including dementia or seizures
- •Active uncontrolled infection (viral, bacterial or fungal infection)
- •Other serious medical illnesses
- •Pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception
- •Previous history of drug allergy to one of the drugs in the study regimen
研究组 & 干预措施
ESHAOx arm
Experimental
Patients who are planned to be treated with ESHAOx chemotherapy
干预措施: Oxaliplatin-based chemotherapy (ESHAOx) (Drug)
结局指标
主要结局
Overall Response rate to ESHAOx chemotherapy
时间窗: within 3 weeks after the completion of the treatment
To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma.
次要结局
- Overall survival, response duration, toxicity profiles(up to 5 years after the completion of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung CancerLung CancerNCT00083161Gundersen Lutheran Health System8
Unknown
2 期
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast CancerBreast CancerNCT01492556Chinese Academy of Medical Sciences100
Unknown
2 期
Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung CancerSmall-cell Lung CancerNCT03613597Guizhou Medical University118
已完成
2 期
Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate CancerProstate CancerNCT00176605Rutgers, The State University of New Jersey15
已完成
2 期
Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin LymphomaAngioimmunoblastic T-cell LymphomaHepatosplenic T-cell LymphomaPeripheral T-cell LymphomaAnaplastic Large Cell LymphomaNCT01336933University of Nebraska34