A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase.

Study Objective

The primary objective is:

• To evaluate the rate of molecular response at 18 months of nilotinib treatment.

The secondary objectives are:

• To evaluate the rate of annual progression and annual events at 12 and 24 months of
treatment
• To evaluate the rate of major molecular response at, as well as by, 12 and 24 months of
treatment
• To evaluate the rate of complete and major cytogenetic response at, as well as by, 12 and 24 months of treatment
• To evaluate the annual rate of progressions and annual rate of events in patients achieving a molecular response at 12 months of treatment.
• To evaluate the rate of molecular response at, as well as by, 12 and 24 months of treatment
• To evaluate the rate of complete haematologic response at, as well as by, 12 and 24 months of treatment
• To evaluate the Event-Free Survival and Overall Survival at 12 months and at 24 months of treatment
• To evaluate the rate of molecular response by 18 months of treatment
• To evaluate the safety and tolerability profile of nilotinib

Participation Conditions

Inclusion Criteria's

• Male or female patients with diagnosis of chronic myeloid leukemia with cytogenetic confirmation of Ph chromosome [t(9;22) translocation].
• Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR (Cross, et al 1994) are eligible as well

Exclusion Criteria's

• Pretreatment with hydroxyurea for > 6 months and imatinib > 3 months is not permitted. The investigator should notify the DMC requesting review of any patient who has
received prior imatinib treatment for 6 or more weeks to ensure that the patient is not failing on imatinib.
• Known impaired cardiac function.
• History of acute (i.e., within 1 year of starting study medication) or chronic pancreatitis
• Treatment with any haematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF) ≤ 1 week prior to starting study drug.
• Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
 

Centre Hospitalier de Luxembourg