Status:
COMPLETED
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study
Eligibility Criteria
Inclusion
- patients currrently participating in Novartis study CAMN107A2109
- imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
- males or females ≥18 years of age
- WHO Performance Status of ≤ 2
- 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
- Impaired cardiac function; use of therapeutic coumarin derivatives
- patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
- patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
- patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
- ,.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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00786812
Start Date
August 1 2008
End Date
January 1 2012
Last Update
February 23 2017
Active Locations (9)
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1
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30130-100
2
Novartis Investigative Site
Curitiba, Paraná, Brazil, 80060-900
3
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
4
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903