JPRN-jRCTs031200375招募中2 期
Phase II study to evaluate efficacy and safety of unrelated peripheral blood stem cell transplantation with post-transplant cyclophosphamide for adult T-cell leukemia/lymphoma
Fukuda Takahiro0 个研究点目标入组 24 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1) Adult T-cell leukemia/lymphoma, acute or lymphoma type
- •2) Patients who have an HLA 6-8/8 matched unrelated peripheral blood stem cell donor
- •3) Age: 20-65 years old
- •4) ECOG performance status: 0 or 1
- •5) Disease status: CR, PR, or, SD
- •6) Written informed consent from the patient
- •7) Patients who are expected to survive for at least 3 months
排除标准
- •1) Severe organ dysfunction in the heart, lung, kidney, or liver
- •2) Uncontrollable ATL lesion in central nervous system
- •3) Uncontrollable diabetes mellitus
- •4) Uncontrollable hypertension
- •5) Coronary artery disease requiring treatment, cardiomyopathy, cardiac failure, or arrhythmia requiring medication
- •6) Acute hepatitis, chronic active hepatitis, or liver cirrhosis
- •7) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest X-ray.
- •8) Infectious disease requiring systemic therapy
- •9) Simultaneous or metachronous (within 5 years) double cancers, except for carcinoma in situ resected by local therapy
- •10) History of lymphoma, myelodysplastic syndrome, or leukemia
- •11) History of anti-CCR4 antibody administration
- •12) Prior hematopoietic stem cell transplantation
- •13) High titer of anti-donor specific HLA antibody
- •14) Positive HIV antibody
- •15) Women during pregnancy or breastfeeding
- •16) Psychological disorder
- •17) Patients who are not eligible for this study at the discretion of the physician
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