Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase ('MACS1252)

Novartis

Status and phase: Completed; Phase 4

Conditions: CML in Chronic Phase

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061177

2009-017775-19 (EudraCT Number)

CAMN107EIC01

Details and patient eligibility

About

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

Enrollment: 1,090 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
• Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
• WHO performance status 0-2
• Laboratory assessments within normal limits
• Written informed consent prior to any study procedures being performed

Exclusion criteria

• Known impaired cardiac function
• History of acute or chronic pancreatitis
• Impaired gastrointestinal function or disease that may alter the absorption of study drug
• Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
• Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,090 participants in 1 patient group

Nilotinib

Experimental group

Description:

This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Treatment:

Drug: Nilotinib