A Phase II, single arm, open label study of treatment-free remission in chronic myeloid leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on Nilotinib - nilotinib suspension study after combined nilotinib/imatinib treatment

ovartis0 sites3 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•Male or female patients \*18 years of age
•ECOG performance status of 0\-2
•Patient with diagnosis of BCR\-ABL positive CML
•Patient has received minimum of 3 years of tyrosine kinase inhibitor treatment (first with imantinib and then switched to nilotinib) since initial diagnosis
•Minimum of 2 calendar years of nilotinib treatment before study entry
•Patient has achieved MR4\.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening.
•Adequate end organ function as defined by:
•\* Direct bilirubin \* 1\.5 x ULN
•\* SGOT(AST) and SGPT(ALT) \* 3 x ULN
•Serum lipase \* 2 x ULN i.e. equivalent to \* Grade 2 NCI\-CTCAE v.4\.03

•Prior AP, BC or allo\-transplant
•Patient has documented MR4\.5 at the time when switched from imatinib to nilotinib
•Patients with known atypical transcript
•Mutation(s) (T351I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform
•mutation testing at study entry if it was not done in the past)
•Dose reductions due to neutropenia or thrombocytopenia in the past 6 months
•Patient ever attempted to permanently discontinue imatinib or nilotinib treatment
•Known impaired cardiac function
•History of acute pancreatitis
•Known presence of a significant congenital or acquired bleeding disorder unrelated to

Not specified