A Phase II Open-Label Study of the Subcutaneous Administration of Omacetaxine in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy.

ChemGenex Pharmaceuticals Inc.0 个研究点目标入组 100 人开始时间: 2009年5月28日最近更新: 2020年1月13日

研究概览

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•1. Male or female patients, age 18 years or older
•2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
•3. Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
•4. Acceptable Renal and Liver Function
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•6. Sexually active patients and their partners must use an effective double barrier method of contraception.

•1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
•2. Myocardial infarction in the previous 12 weeks.
•3. Other concurrent illness which would preclude study conduct and assessment uncontrolled and active infection, and positive human immunodeficiency virus (HIV) or positive Human T-lymphotropic virus (HTLV) I/II status, whether on treatment or not.
•4. Pregnant or lactating.
•5. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
•6. Lymphoid Ph+ blast crisis
•7. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.

发起方