Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
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|ClinicalTrials.gov Identifier: NCT01819389|
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : January 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Chronic, BCR-ABL Positive||Drug: Imatinib and Nilotinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Imatinib and nilotinib combination
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.
Drug: Imatinib and Nilotinib
- Major molecular response [ Time Frame: 6 months ]Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
- Drugs adverese effects [ Time Frame: 6 months ]Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.
- Adherence [ Time Frame: 6 months ]Every month adherence will be assessed with a questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819389
|Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"|
|Monterrey, Nuevo Leon, Mexico, 64460|