jRCTs041210054招募中不适用
A multicenter phase II study in children and adults with newly diagnosed T-cell acute lymphoblastic leukemia (JPLSG-ALL-T19)
未提供0 个研究点目标入组 259 人开始时间: 2021年8月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 259
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 65age old not（—）
- 性别
- All
入选标准
- •(1) Diagnosis of T cell ALL
- •(2) Age < 65 years old at diagnosis
- •(3) ECOG performance status (PS) score of 0-
- •However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
- •(4) Sufficient organ function satisfying the laboratory data listed below;
- •i) Direct bilirubin: = or < 2.0 mg/dL
- •ii) Creatinine: = or < 2.0 mg/dL
- •iii) Normal ECG and UCG. Although UCG is not essential, it should be examined when cardiac function may be low. EF = or > 50% when it is examined.
- •iv) SpO2 = or > 94% in room air
- •(5) Written informed consent obtained from patient or guardians.
排除标准
- •(1) BCR-ABL1 positive ALL
- •(2) Down syndrome
- •(3) Intracranial hemorrhage = or > grade 3 in CTCAE v5.0
- •(4) Malignant hypertension
- •(5) Pulmonary fibrosis
- •(6) Interstitial pneumonia
- •(7) Liver cirrhosis
- •(8) Positive anti-HIV antibody or HBs antigen
- •(9) Uncontrolled diabetes
- •(10) Uncontrolled infection
- •(11) Deep thrombosis requiring treatment.
- •(12) Mental disorder that will likely make it impossible to complete treatment according to protocol
- •(13) Active double cancer
- •(14) Pregnant or lactating woman, or high possibility of pregnancy
- •(15) Past History of congenital or acquired immunodeficiency
- •(16) Any inappropriate status judged by physician
结局指标
主要结局
-
Three year event free survival
次要结局
未报告次要终点
研究者
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