JPRN-jRCTs041190088进行中（未招募）2 期
Phase II study of intensive treatment for newly diagnosed elderly acute myeloid leukemia, fitted for standard chemotherapy like younger adults, by Japan Adult Leukemia Study Group (JALSG-GML219) - JALSG-GML219
Ito Yoshikazu0 个研究点目标入组 128 人开始时间: 2019年11月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- >= 65age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •(1) Newly diagnosed as acute myeloid leukemia
- •(2) Ages, 65-74
- •(3) ECOG performance status score 0-2
- •(4) Having sufficient function of liver, kidney, lung and heart
- •(5) Expected to be alive for more than 3 months at the enrollment
- •(6) Having ability to concent in written forms following sufficient explanation regarding this study
排除标准
- •(1) Having treatment history of myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement or myelosysplastic/myeloproliferative neoplasms
- •(2) Therapy-related myeloid neoplasms other than AML
- •(3) APL with PML-RARA, myeloid sarcoma or myeloid proliferations associated with Down syndrome
- •(4) Hypoplastic leukemia (less than 20% hypocellularity in bone marrow biopsy along with the absence of fibrotic tissue or other hematological tumors)
- •(5) Having treatment history for preceding bone marrow failure employing cytotoxic or DNA hypomethylating agents
- •(6) Having 20-30% bone marrow blasts, not included in AML with recurrent genetic abnormality of the WHO classification, included in myelodyplastic syndromes in FAB classification, having dysplastic features and preceeding dyshemopoesis, and having no indication for cytotoxic treatment
- •(7) Having other active cancer
- •(8) Having history of myocardial infarction within a year
- •(9) Having uncontrolable diabetes mellitus
- •(10) Having severe infectious disease
- •(11) Having liver cirrhosis
- •(12) Having deep thrombosis to be treated
- •(13) Having necessity of admission or frequent treatment modification for mental disoreders
- •(14) Positivity of HBs antigen or HIV antibody
研究者
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