Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients (ENESTxtnd)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254188

CAMN107E2401

Details and patient eligibility

About

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion criteria

• Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
• Uncontrolled congestive heart failure or hypertension
• Myocardial infarction or unstable angina pectoris within past 12 months
• Known T315I mutations
• QTcF >450 msec
• Significant arrhythmias

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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421 participants in 1 patient group

Nilotinib

Experimental group

Description:

300 mg BID

Treatment:

Drug: Nilotinib