JPRN-jRCTs041180145已完成2 期
A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia - ALL-T11
Watanebe Arata0 个研究点目标入组 364 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 364
研究概览
简要总结
The clinical trial for newly diagnosed T-ALL patients aged less than 25 years old cooperatively conducted by Japan Children's Cancer Study Group and Japan Adult Leukemia Study Group has been implemented. This trial was a BFM-based treatment with the intensification of nelarabine and L-asparaginase. It showed encouraging and comparable outcomes to other clinical trials with acceptable toxicities.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 至 <= 24age old（—）
- 性别
- All
入选标准
- •1) diagnosis of T-ALL (CD3+ or cyCD3+ and more than one is positive among CD2, CD5, CD7, CD8)
- •2) age less than 25 years old
- •3) ECOG performance status (PS) acore of 0-2.However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
- •4) no history of previous chemotherapy or radiation therapy
- •5) sufficient hepatic and renal function satisfying the laboratory data listed below ;
- •(1)T-Bili: within 3x of age adjusted upper-limit of normal range.
- •(2)Creatinine: within 3x of age adjusted upper-limit of normal range.
- •6) written informed consent obtained from patient or guardians.
排除标准
- •1) Intracranial hemorrhage more than grade 3 of CTCAE v4.0
- •2) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
- •3) pregnancy or high possibility of pregnancy and giving suck woman.
- •4) history of congenital or acquired immunodeficiency.
- •5) Down syndrome.
- •6) QTfc, corrected by Fridericia formula as QTfc = QT/RR cube root, is more than 0.45 seconds.
- •7) any inappropriate status judged by physician.
研究者
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