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A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. | between 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response | 24 months | |
| To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study | 24 months |
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Inclusion Criteria:
Stratum 1:
Stratum 2:
Exclusion Criteria:
Stratum 1 and stratum 2:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticlas | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San José, Bogotá, Colombia | Bogotá | Colombia | ||||
| Banco Municipal de Sangre |
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| To follow loss of HR (after previous confirmed HR for AP and CHR for CP) | 3, 6 and 12 months |
| Caracas |
| Venezuela |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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