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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib and nilotinib combination | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib and Nilotinib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Major molecular response | Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drugs adverese effects | Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Every month adherence will be assessed with a questionnaire | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Hematologia, Hospital Universitario "José E. Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20507881 | Background | Schoffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD. A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol. 2010 Oct;21(10):1990-1998. doi: 10.1093/annonc/mdq076. Epub 2010 May 27. | |
| 22986736 |
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| Gomez-Almaguer D, Tarin-Arzaga L, Cantu-Rodriguez O, Ceballos-Lopez A. More about imatinib and nilotinib combination therapy in chronic myeloid leukemia. Acta Haematol. 2013;129(1):18-9. doi: 10.1159/000342455. Epub 2012 Sep 12. No abstract available. |
| 22286512 | Background | Zhu GR, Ji O, Ji JM, Zhang YC, Wu Y, Yu H, Jiang PJ, Shen Q. Combining nilotinib and imatinib improves the outcome of imatinib-resistant blast phase CML. Acta Haematol. 2012;127(3):152-5. doi: 10.1159/000333107. Epub 2012 Jan 27. |
| 26871197 | Derived | Gomez-Almaguer D, Saldana-Vazquez R, Tarin-Arzaga L, Herrera-Rojas MA, Vazquez-Mellado de Larracoechea A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Combination of low-dose imatinib plus nilotinib for the treatment of chronic-phase chronic myeloid leukaemia after imatinib failure. Hematology. 2016 Aug;21(7):411-4. doi: 10.1080/10245332.2015.1119369. Epub 2016 Feb 16. |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| C498826 | nilotinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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