Chronic Myeloid Leukemia
Conditions
Interventions
All patients will be treated with 300 mg BID nilotinib or 400 mg BID nilotinib
Sponsors
Novartis Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Includion criteria 1) ECOG Performance Status of 0, 1, or 2 2) Patient with diagnosis of BCR-ABL positive CML CP 3) Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis 4) Patient has at least 2 years of nilotinib treatment prior to study entry 5) Patient has achieved MR4.5 during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening 6) Adequate bone marrow and organ function meeting laboratory criteria
Exclusion criteria
Exclusion criteria: Main Exclusion criteria 1) Prior AP, BC or allo-transplant 2) Patient has documented MR4.5 at the time when switched from imatinib to nilotinib 3) Patients with known atypical transcript. 4) CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past 5) Severe and/or uncontrolled concurrent medical disease 6) History of other active malignancy within 5 years prior to study entry 7) Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy To evaluate the proportion of patients in Treatment-free remission (TFR) within 12 months following nilotinib cessation | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy To evaluate the proportion of patients in TFR, PFS, TFS, OS, To characterize the kinetics of BCRABL transcript after re-start of nilotinib therapy | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Greece, Israel, Korea, Mexico, Poland, Russia, Singapore, Spain, Tunisia, United Kingdom, United States
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma K.K.
Outcome results
None listed