EUCTR2013-002388-25-IT进行中（未招募）1 期
Phase II study to evaluate the safety and the efficacy of rituximab, cyclophosphamide, non-pegylated liposomal doxorubicin, vincristine and prednisolone (R-COMP 14) as front-line therapy for patients with active Waldenstrom Macroglobulinemia
Azienda Ospedaliera Ospedali Riuniti Marche Nord0 个研究点目标入组 40 人开始时间: 2014年1月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent prior to any study procedures being performed
- •Diagnosis of untreated Waldenstrom Macroglobulinemia
- •Age >18 and <80 years.
- •Karnofsky score = 70% or WHO =1.
- •Adequate renal, pulmonary and hepatic function:
- •Serum creatinine < 2 mg/dl;
- •Sat O2 = 96%;
- •ALT/AST = 2.5 x N.
- •Fertile female must use adequate contraceptive precautions.
- •Patients with active disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •People unable or unwilling to give informed consent.
- •Age < 18 or > 80 years.
- •HIV positivity.
- •HCV positivity with high viral load..
- •HBs Ag positivity.
- •Pregnancy or nursing female
- •Current uncontrolled infection.
- •Patients with a history of other malignancies within 2 years prior to
- •study entry.
- •Treatment with any other IMP, or participating in another clinical trial
- •within 30 days prior to entering this study.
- •Lacking of at least one criteria of active disease.
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