EUCTR2004-001907-36-GB进行中(未招募)1 期
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) - L-001079038 in Relapsed DLBC
Merck Sharp & Dohme Limited0 个研究点目标入组 50 人开始时间: 2005年2月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
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
入选标准
- •Eligible patients must be =18 years with relapsed DLBCL (de novo or transformed)following standard first line chemotherapy and at least one salvage systemic therapy. Patients who have disease that is refractory to their last chemotherapy regimen are not eligible. Other eligibility criteria include: 3 months or longer without evidence of progression on the most recent treatment; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; = 4 weeks from prior chemotherapy, radiation therapy, major surgery, or other investigational anticancer therapy; and adequate hematologic (absolute neutrophil count >1000/mm3, platelets > 75,000 /mm3), hepatic and renal function.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients to be excluded from the trial if:
- •had prior treatment with any HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ 824);
- •had a response or stable disease less than 3 m to the most recent treatment;
- •have failed more than 3 prior regimens ;
- •have had an allogenenic transplantation.
- •have certain co-mobility including HIV infection.
研究者
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