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 enrollmentStarted: TBDLast updated: April 29, 2024

Study Overview

No summary available.

•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
•* Alkaline phosphatase * 2.5 x ULN
•* Serum creatinine < 1.5 x ULN
•Patients must have the following electrolyte values above LLN limits or corrected to be within normal limits with supplements prior to
•first dose of study medication:
•* Potassium
•* Magnesium
•* Total calcium (corrected for serum albumin)
•Patients must have normal marrow function as defined:
•* Absolute Neutrophil Count (ANC) * 1.5 x 109/L
•* Hemoglobin * 9.0 g/dL
•* Platelets * 100 x 109/L

•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
•History of other active malignancy within 5 years prior to study entry
•Treatment with other investigational agents (defined as not used in accordance with the
•approved indication) within 4 weeks of Day 1
•Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and
•the treatment cannot be either discontinued or switched to a different medication prior to
•study entry.

Sponsor