None listed
Conditions
Interventions
Group BMS-354825 Type of group
BMS-354825 will be administered continuously at an oral dose of 70 mg twice a day. A treatment cycle will consist of 4 weeks (28 days). The administration will be in the morning (approximately between 8 and 9 o clock) and in the evening (approximately between 20 and 21 o clock).
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients must provide written informed consent. 2) Subjects with accelerated phase chromic leukemia, which are Ph + chromosome (or BGR / ABL +), whose disease has primary or acquired haematological resistance to the imatinib mesylate. or are intolerant to Imatinib mesylate. 3) Available for scheduled follow-up 4) Score of 0 - 2 in the performance status ECOG 5) Adequate liver function. 6) Adequate renal function. 7) Serum levels of potassium and magnesium within normal limits. 8) Men and women 18 years of age or older
Exclusion criteria
Exclusion criteria: 1) MEF that are not willing or able to use a method of birth control. 2) MEF who are using a prohibited contraceptive method. 3) MEF who are pregnant or breast-feeding 4) Women who have obtained a positive result in the pregnancy test performed. 5) Sexually active men whose sexual partners may become pregnant, unwilling or unable to use a method of birth control that is acceptable 6) Subjects that are eligible and willing to undergo a transplant during the selection period 7) Severe uncontrolled 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. 10) History of significant hemorrhagic disorder not associated with CML 11) Concurrent incurable neoplasia different from CML. 12) Evidence of organic dysfunction or dysfunction dlgestiva. 13) Subjects who received any of the following: a) Imatinib mesylate in the previous 7 days b) Interferon or cytarabine in the previous 14 days c) An antineoplastic molecule within the previous 14 days d) Any other antineoplastic or investigational drug within the previous 28 days. 14) Individuals currently taking: Quinidine, procainamide, disopyramide, Amiodarone, sotalol, ibutilide, dofetilide, erythromlcins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cizapride, bepridil, droperidol, methadone, arsenic, c-orochin , domperidone, halofantrine, levomethadyl, panetamidine, sparfloxacin, lidoflazine. 15) Individuals who are taking medications that irreversibly inhibit platelet function. 16) Previous therapy with BMS-354825 17) Prisoners or patients, who have been detained, may not be enrolled in this study. against your will
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) White blood cell count 1000 / mm3. 3) Platelets> 100,000 / mm3 4) No blasts or promyelocytes in peripheral blood. 5) Blasts in bone marrow <5%. 6) <5% myelocytes plus metamyelocytes in peripheral blood. 7) <20% of basophils in peripheral blood and <20% of basophils in bone marrow. 8) Without extramedullary commitment Measure:Complete hematologic response Timepoints:At the end of each therapy cycle (28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Blasts in bone marrow 100,000 / mm3 5) No extra joint disease other than spleen and liver. Measure:Return to the chronic phase (RFC) Timepoints:At the end of each therapy cycle (28 days) | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Italy, Peru, Sweden, United Kindgdom
Outcome results
None listed