Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
Phase 3
Completed
- Conditions
- Leukemia, Myeloid, Chronic, BCR-ABL Positive
- Interventions
- Registration Number
- NCT01819389
- Lead Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imatinib and nilotinib combination Imatinib and Nilotinib All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Drugs adverese effects 6 months Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.
Trial Locations
- Locations (1)
Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
🇲🇽Monterrey, Nuevo Leon, Mexico