Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
Chronic Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL
Eligibility Criteria
Inclusion Criteria: Philadelphia chromosome positive or bcr-abl gene positive Chronic Myelogenous Leukemia (CML) Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL) Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2 Men and women, ages 20 - 75 Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized Exclusion Criteria: Subjects who are eligible and willing to undergo transplantation at pre-study Women who are pregnant or breastfeeding Uncontrolled or significant cardiovascular disease History of significant bleeding disorder unrelated to CML or ALL Adequate hepatic function Adequate renal function Medication that increase bleeding risk Medication that change heart rhythms Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
A1
A2
A3
B1
B2
B3