CTRI/2016/02/006589已完成未知
A prospective, open label, randomized, active control, parallel design, comparative pharmacokinetics study of Intramuscular Pegaspargase (Hamsyl) of Gennova Biopharmaceuticals Ltd versus Intramuschlar Oncaspar in Pediatric patients with relapsed cased of Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 29
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
- •Relapsed cases of Acute Lymphoblastic Leukemia (ALL)
- •Diagnostic Criteria: presence of blasts in the bone marrow that are myeloperoxidase negative and TdT positive and/or expressed an ALL immunophenotype with monoclonal antibodies directed against precursor B-cell or T-cell lineage
排除标准
- •Patients receiving cytotoxic regimen without pegaspargase or other diseased status will be excluded.
- •Contraindication as per SPC
- •History of thrombosis with prior L-asparaginase therapy
- •History of pancreatitis with prior L-asparginase therapy
- •History of hemorrhagic events with prior L-asparaginase therapy
- •Patients with ALL FAB L3 and blastic crisis of chronic myelogenous leukemia as well as HIV-positive patients were excluded
- •Billirubin levels more than 34.2 µM (2 mg/dL)
- •Creatinine levels more than 178.8 µM (2 mg/dL).
研究者
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