CTRI/2018/08/015396尚未招募未知
A prospective, open label, randomized, parallel design study of 4 generic formulations of intramuscular L-asparaginase in childhood precursor B-cell Acute Lymphoblastic Leukemia (ALL)
ImPaCCT Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Intermediate risk precursor B cell ALL patients as defined by the ICICLE protocol:
- •1. Presenting WC greater than and/or equal to 50,000/mm3
- •2. No CNS disease
- •3. At risk clinical features like: bulky lymph nodes ( > 5 cm in peripheral region and in the chest > 5 cm on CT scan or occupying > 1/3rd diameter on chest x-ray) and/or bulky liver/spleen reaching beyond midway to umbilicus and/or presence of testicular disease. Absence of high risk cytogenetics including hypodiploidy.
排除标准
- •1. Patients pre-treated before diagnosis
- •2. Pre-existing renal disease before starting treatment (Creatinine > 1.1 mg/dL)
- •3. Pre-existing hyperbiliribuinemia at diagnosis (Bilirubin > 2 mg/dL)
- •4. High Risk Patients as defined by ICICLE protocol
研究者
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