JPRN-jRCT2073210013招募中2 期
Autologous Dendritic Cell Vaccine Therapy Targeting HTLV-1 Specific Antigen for Adult T-Cell Leukemia/Lymphoma A Phase II multicenter randomized controlled Study - Autologous DC Vaccine Therapy Targeting HTLV-1 Specific Antigen for ATLL A Phase II Study
Suehiro Youko0 个研究点目标入组 34 人开始时间: 2021年4月20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
- 34
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
- •(1) Pre-treated ATL patient with following criterias
- •1) PR or better results with the pretreatment
- •2) ATL in acute type lymphoma type, or chronic type with unfaborable prognostic factors
- •3) Pre-treatment of chemo therapy and/or radio therapy
- •4) no nessecity of having target lesion (mesurable mass, ATL cells in peripheral blood, or skin lesion)
- •(2) Positive for any of HLA-A*0201, *2402, *1101, or *0207
- •(3) 20 years old and over
- •(4) No recurrence has been confirmed for at least four weeks after previous therapy (chemo therapy and/ or radio therapy)
- •(5) ECOG performance status 0 or 1
- •(6) Meet the following criteria for organ function
- •serum-Cr < 2.0 mg/dL.
- •AST, ALT < 3 X ULN value,
- •(7) Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis
- •(8) Writtenn consent for participation to this study
排除标准
- •(1) Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases.
- •(2) Patients who receive systemic administration of steroid or immunosuppressive agents.
- •(3) Patients with severe active infectious disease (except for HTLV-1 infection)
- •(4) Patiients with allogeneic transplantation have been carried out or scheduled.
- •(5) Patients with severe allergy and/ or drug hypersensitivity. Patients with a history of shock due to benzylpenicillin.
- •(6) Presence of active central nervous system lesion
- •(7) Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant
- •(8) Severe psychiatric disorder
- •(9) History of HAM/TSP
- •(10) Active multiple cancers
- •(11) Inappropriate for study entry judged by an attending physician
研究者
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