A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)

Astex Pharmaceuticals, Inc.8 个研究点分布在 2 个国家目标入组 40 人开始时间: 2002年7月1日最近更新: 2007年12月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Astex Pharmaceuticals, Inc.
入组人数: 40
试验地点: 8

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 2 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed diagnosis of CML accelerated phase
•Ph chromosome-positive
•Previous treatment with imatinib mesylate resulting in:
•i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
•Patients must have recovered from the side effects of previous CML therapy for accelerated phase with the exception of hydroxyurea
•Age >/= 2 years
•Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of the liver, serum creatinine </= 2 x ULN
•WHO performance status 0-3
•A negative serum hCG pregnancy test in patients of childbearing potential
•Able to give signed informed consent directly or through a parent or guardian for minors

排除标准

•Leukemic involvement of the central nervous system
•Active malignancy other than CML or non-melanoma cancer of the skin
•Previous treatment for CML with another investigational agent within 28 days of study entry
•At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
•Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
•Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
•Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
•Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
•Patients with systemic, uncontrolled infections

研究者

发起方

Astex Pharmaceuticals, Inc.

申办方类型

Industry

研究点 (8)

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