Phase II Study of BMS-354825 in Patients with Chronic Myeloid Myeloid Phase Ieloblastic Leukemia Who Are Resistant or Intolerant to Treatment with Imatinib Mesylate

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 0 人开始时间: 2005年4月28日最近更新: 2023年9月4日

研究概览

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•1) Patients must provide written informed consent
•2) Subjects with chronic myeloid leukemia in the blast myeloid phase that are Ph + chromosome (or BCR / ABL +), whose disease has primary or acquired hematological resistance to imatinib mesylate, or are intolerant to imatinib mesylate.
•3) Available for a scheduled follow-up.
•4) Score of 0 - 2 in the EGOG performance status.
•5) Adequate liver function.
•6) Adequate renal function.
•7) Serum levels of potassium and magnesium within normal institutional limits.
•8) Men and women 18 years of age or older.

•1) MEF that are not willing or able to use a method of birth control that is acceptable.
•2) MEF who are using a prohibited contraceptive method.
•3) MEF who are pregnant or breastfeeding.
•4) Women who have obtained a positive result in the pregnancy test performed during enrollment.
•5) Sexually active men whose sexual partners may become pregnant, who are unwilling or unable to use a method of birth control
•that is acceptable.
•6) Subjects who are eligible and willing to undergo a transplant during the selection period.
•7) Severe non-controlled medical condition or active infection that could impair the possibility of the subject receiving the protocol therapy.
•8) Significant or uncontrolled cardiovascular disease.
•9) Dementia or mental state altered that would prevent understanding the informed consent.
•10) History of significant hemorrhagic disorder not associated with CML.
•11) Concurrent incurable neoplasia different from CML.
•12) Evidence of orogenic dysfunction or digestive dysfunction that would prevent the administration of therapy.
•13) Subjects who received: Imatinib mesylate in the 7 days prior to admission, Interferon in the 14 days prior to admission, antineoplastic molecule therapy within 14 days prior to admission, any other antineoplastic or investigational drug.
•15) Individuals who are taking medications that irreversibly inhibit platelet function

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