An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Novartis Pharmaceuticals1 site in 1 country89 target enrollmentAugust 2008

InterventionsNilotinib

Overview

Phase: Phase 4
Intervention: Nilotinib
Conditions: Chronic Myeloid Leukemia
Sponsor: Novartis Pharmaceuticals
Enrollment: 89
Locations: 1
Primary Endpoint: Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
Status: Completed
Last Updated: 9 years ago

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

January 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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