NL-OMON34200已完成不适用
A non-randomized, open-label study to characterize the pharmacokinetcs of Glivec/Gleevec (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders. - CSTI571A2110
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 2
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
- 2 至 11（—）
入选标准
- •1. Patients must be 1 to less than 4 years of age at study entry.
- •2. Written informed consent must be signed by the patient*s parent or legal guardian.
- •3. Patients must have the diagnosis of CML or Ph+ ALL or other imatinib indicated hematological disorders.
- •4. Lansky score must be >= 50
- •5. Patient must have adequate end organ function as defined by
- •Total bilirubin < 1.5 x ULN
- •SGPT (ALT) and SGOT (AST) < 2.5 x UNL
- •Creatinine < 1.5 x ULN
排除标准
- •1. Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
- •2. Patients who previously received radiotherapy to >= 25% of the bone marrow, with the
- •exception of patients who received total body radiation as part of a preparatory regimen
- •for hematopoetic stem cell transplant (HSCT)
- •3. Patients receiving antibacterial and antipyretic medication to treat active infection
- •4. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
- •5. Patients whose parents or legal guardian, in the opinion of the investigator, are unlikely to comply with the protocol or safety monitoring requirements
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