Chronic Myeloid Leukemia
Conditions
Keywords
Leukemia, adult chronic myeloid leukemia, imatinib, nilotinib
Brief summary
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study
Interventions
DRUGNilotinib
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients currrently participating in Novartis study CAMN107A2109 2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC) 3. males or females ≥18 years of age 4. WHO Performance Status of ≤ 2 5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor
Exclusion criteria
1. Impaired cardiac function; use of therapeutic coumarin derivatives 2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days 3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control 4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy 5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months | 3 - 24 months |
Countries
Brazil
Outcome results
None listed