Status:
COMPLETED
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Leukemia, Myeloid, Chronic, BCR-ABL Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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
- Patients in blast crisis.
- Pregnant women
- Patients without a contraception method.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01819389
Start Date
October 1 2012
End Date
August 1 2013
Last Update
January 7 2014
Active Locations (1)
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1
Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
Monterrey, Nuevo León, Mexico, 64460