Leukemia, Myeloid, Chronic, BCR-ABL Positive
Conditions
Keywords
Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib
Brief summary
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.
Interventions
DRUGImatinib and Nilotinib
Sponsors
Novartis Pharmaceuticals
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major molecular response | 6 months | Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drugs adverese effects | 6 months | Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 months | Every month adherence will be assessed with a questionnaire |
Countries
Mexico
Outcome results
None listed