EUCTR2016-002782-57-FR进行中（未招募）1 期
Phase 2 study of Brentuximab Vedotin associated with CHP followed by consolidation with high-dose therapy / autologous stem-cell transplantation as frontline treatment of patients with enteropathy-associated T-cell lymphoma type 1. - EATL001
Institut des maladies génétiques - Imagine0 个研究点目标入组 25 人开始时间: 2016年11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
- 25
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
- •1. Histologically confirmed diagnosis of EATL based on criteria established by the World Health Organization (WHO) 2016 Classification of Tumors of Haematopoietic and Lymphoid Tissues.
- •2. EATL should be CD30-positive with a threshold of 10%.
- •3. Patients aged = 18 years and < 70 years at the time of study entry.
- •4. ECOG performance status 0 to 3 at time of study entry...
- •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 5
排除标准
- •1. Participants must not have been treated with any prior chemotherapy for EATL. Patients with previous treatment for refractory celiac disease (i.e., immunosuppressive or immunoregulatory drugs) may be included.
- •2. Known central nervous system involvement by EATL.
- •3. Active chronic hepatitis B or C.
- •4. HIV positive serology.
- •5. HTLV-1 positive serology.
- •6. Participation in any study of an investigational drug within 30 days prior to study entry...
研究者
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