None listed
Conditions
Interventions
Group 1 Type of group
The treatment will begin with 70 mg PO twice a day (BID), giving continuous daily doses. The subjects will receive treatment until progression of the disease despite having escalated the dose to the highest level considered safe, intolerable toxicity or until the study is withdrawn.
Group name:Group 2 Type of group
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients must provide written informed consent. 2) Subjects with chronic myeloid leukemia in the blastic lymphoid phase that are Ph + chromosome (or BCR / ABL-h), whose disease has primary or acquired haematological resistance to imatinib mesylate, or are intolerant to imatinib mesylate. 3) Available for a 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 institutional 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 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
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 blood response Timepoints:- Blood counts: Every 7 days - Bone marrow analysis: Every month | — |
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:- Blood counts: Every 7 days - Bone marrow analysis: Every month | — |
Countries
Austria, Denmark, Finland, Germany, Italy, Peru, Sweden, United Kindgdom
Outcome results
None listed