None listed
Conditions
Interventions
This group will be treated with BMS-354825 140 mg PO QD every day until intolerable toxicity occurs or progression of the disease is confirmed.
GROUP 1 Type of group
This group will be treated with BMS-354825 70 mg PO BID every day until intolerable toxicity or progression of the disease is confirmed.
Group name:GROUP 2 Type of group
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Written informed consent. 2) Subjects with accelerated phase chronic myeloid leukemia that are Ph + chromosome (or BGR / ABL +). 3) Subjects with chronic myeloid leukemia in myeloid or lymphoid blast phase with Ph + chromosome (or BCR / ABL +). 4) Subjects with ALL with Ph + chromosome (or BCR / ABL +). 5) Score of 0 - 2 in the performance status (PS) ECOG. 6) Adequate liver function. 7) Adequate renal function. 8) Serum levels of Na, K, Mg, P and levels of total serum Ca or ionized Ca should be greater than or equal to the lower normal limit. 9) Men and women 18 years of age or older. 10) Women of childbearing age (MEF) should use a method of birth control that is adequate to avoid pregnancy throughout the study.
Exclusion criteria
Exclusion criteria: 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) Women who are pregnant or breastfeeding. 4) Women who have obtained a positive result in the pregnancy test. 5) Sexually active men whose sexual partners are MEF, who are unwilling or unable to use a method that is acceptable. 6) Subjects that are eligible for an immediate autologous or allogeneic stem cell transplant. 7) Subjects with active CNS commitment. 8) Uncontrolled severe medical trauma or active infection. 9) Significant or uncontrolled cardiovascular disease. 10) Dementia or mental state altered. 11) History of significant hemorrhagic disorder not associated with CML. 12) Concurrent incurable neoplasia different from CML. 13) Evidence of organic dysfunction or digestive dysfunction. 14) Subjects who received any of the following: a) Imatinib mesylate in the 7 days prior to admission. b) Interferon or cytarabine in the 7 days prior to admission. c) A small target antineoplastic molecule within 7 days prior to admission. d) Any other neoplastic or investigational drug. 15) Individuals who are currently taking drugs, of which it is generally accepted that there is a risk that they cause Torsade de Pointes. 16) Individuals who are taking drugs that inhibit platelet function irreversibly. 17) Previous therapy with BMS-354825. 18) Prisoners or patients who are detained against their will can not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete blood count. Biopsy / bone marrow aspirate. Measure:Primary Efficacy: Complete haematological response rate (RHC). Timepoints:Complete blood count: Day 1, weekly for 6 weeks, week 8 and 12, then monthly for 9 months and then every 3 months until the end of treatment. Biopsy / bone marrow aspirate: Day, then monthly for 3 months, then every 3 months for 3 months and finally every 6 months until the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Complete blood count. Biopsy / bone marrow aspirate. Cytogenetic analysis. Measure:Secondary effectiveness: Global haematological response (RHG), cytogenetic response (RCy), the difference of RHC between the treatment branches, the difference of RHG between the treatment branches, the time to the RHC and the RHG and the duration, the free survival of progression and the global survival. Timepoints:Complete blood count: Day 1, weekly for 6 weeks, week 8 and 12, then monthly for 9 months and then every 3 months until the end of treatment. Biopsy / bone marrow aspirate: Day, then monthly for 3 months, then every 3 months for 3 months and finally every 6 months until the end of treatment. Cytogenetic analysis: Day, then monthly for 3 months, then every 3 months for 3 months and finally every 6 months until the end of treatment. ; Outcome name:Monitoring and stratification of adverse effects according to version 3.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE). Measure:Safety of the treatment. Timepoints:At the time the event is presented. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea South, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed