Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.

The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.

The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.

Inclusion Criteria:

• CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
• Patients with grade II or higher adverse events.
• CML patients not suitable for stem cell transplantation.

Exclusion Criteria:

• Patients in blast crisis.
• Pregnant women
• Patients without a contraception method.