JPRN-jRCT2080221940未知1 期
Phase 1/2 clinical study of forodesine in Japanese recurrent/refractory peripheral T-cell lymphoma
MUNDIPHARMA K.K.0 个研究点目标入组 49 人开始时间: 2012年10月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 49
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 ot applicable（—）
- 性别
- All
入选标准
- •#Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
- •#Recurrent/refractory patients with a treatment history of at least one regimen, and who achieved at least a partial response to the latest treatment with an antineoplastic drug.
- •#Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
- •#Patients expected to survive for at least 3 months.
- •#ECOG PS 0-1.
- •#Patients with adequate organ function.
- •#Patients from whom written consent has been obtained prior to study initiation.
排除标准
- •#Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
- •#Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
- •#Patients who received another study drug within 28 days prior to initial administration of the study drug.
- •#Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
- •#Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
- •#Patients with cerebral metastasis or central nervous system lesion or a past history.
- •#Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
- •#Patients with severe cardiovascular disease.
- •#Patients with congenital long QT syndrome.
- •#Patients with QTcF >0.48 sec.
- •#Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
- •#Patients positive for CMV antigen on immunological investigation.
- •#Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
- •#Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
研究者
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