NCT01848652终止2 期
Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Answer at treatment
研究概览
简要总结
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.
This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an indication against these treatments.
- •Refractory disease is defined by the absence of objective response to treatment or relapse within 3 months of it. A relapse is defined as disease progression after obtaining a complete or partial response.
- •Age greater than or equal to 18 years
- •Performance Index less than 4
- •Illness measured by CT or MRI
- •Hematologic adequate: neutrophils> 1.5 x 106 / L, platelets> 100x106 / L
- •Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the normal laboratory
- •Adequate renal function: creatinine clearance greater than 60 ml / min
- •adequate cardiac function measured by ejection fraction of the left ventricle> 50% by echocardiography
- •Informed consent signed
- •Negative pregnancy test for women of childbearing age
- •Able to understand the arrangements for monitoring the study and to comply
- •Corticosteroids are only accepted during the first cycle
排除标准
- •Patients with immunosuppression from any cause (HIV, history of transplantation, immunosuppressive treatments ...)
- •Prior treatment MYOCET ® or other anthracycline
- •Active infection
- •Surgery large (more than 3 days hospitalization) within 28 days before enrollment in the study, except for a diagnostic neurosurgical
- •Hypersensitivity to any component of the treatment
- •Contraindications to the administration of MYOCET ® and / or dexamethasone Participation in a clinical trial within 4 weeks prior to study entry
研究组 & 干预措施
MYOCET
Experimental
干预措施: infusion of MYOCET (Drug)
结局指标
主要结局
Answer at treatment
时间窗: after 2 cycles of treatment (84 days)
Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®).
次要结局
- Tolerance at treatment(after each cycle and until the end of follow)
研究者
研究点 (3)
Loading locations...
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