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Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib | Experimental | nilotinib 400mg BID for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of improvement of Dasatinib-related adverse events | at 3 months of nilotinib treatment |
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Inclusion Criteria:
Men and women ≥ 19 years old
Performance status (ECOG) of 0, 1, or 2
Chronic phase or accelerated phase chronic myeloid leukemia being treated for more than two weeks, switch to nilotinib.
Appropriate target organ function defined as;
- Bilirubin < 1.5 X ULN- Liver function test, AST (SGOT) and ALT (SGPT) < 2.5 X ULN- Creatinine < 1.5 X ULN- Serum amylase and lipase ≤ 1.5 X ULN- Alkaline phosphatase ≤ 2.5 X ULN (only if not related to tumor)
Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to the start of study drug administration.
Should have laboratory results as follows.
- Potassium ≥ LLN- Magnesium ≥ LLN- Phosphorus ≥ LLN
Voluntary, signed and dated informed consent prior to any study procedures being performed
Exclusion Criteria:
Subjects with the T315I mutation
Mutation known to be associated with low sensitivity to nilotinib(e.g., Y253H, E255K, E255V, F359V),
Cardiac function abnormalities as follows are found.
Cytopathologically confirmed central nervous system lumbar puncture (spinal tapping is not needed if it is not suspected of association with central nervous system)
Severe or uncontrolled disease (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection)
History of significant congenital or acquired, bleeding disorder unrelated to cancer
25% or more of bone marrow has been treated with prior radiotherapy
Not recovered from prior surgery or having a major surgery within 4 weeks from Day -1 of the study
Treated with other investigational product within 30 days
History of noncompliance with medical treatment or unable to voluntarily provide the written signed and dated informed consent
Other primary cancer which is currently clinically significant and requires active treatment
Currently treated with a strong CYP3A4 inhibitor (e.g., erythromycin, ketoconazole, itraconazol, voriconazol, clarithromycin, telithromycin, ritonavir, mibefradil), and the treatment cannot be stopped or switched to other drug before the start of study drug administration (For a complete list, refer to this link: http://medicine.iupui.edu/flockhart/table.htm.)
Gastrointestinal dysfunction or gastrointestinal disease that may significantly change the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass)
History of acute pancreatitis within the past 1 year or history of chronic pancreatitis
Acute or chronic uncontrolled liver, pancreas or severe renal disease unrelated to the disease
Currently treated with a drug which may prolong QT interval, and the treatment cannot be stopped or switched to other drug before the start of study drug administration (For a complete list of products which prolong QT interval, refer to http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm)
Pregnant women, breast-feeding women
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| 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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