A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase

UMIN ID: UMIN000002007

Registered date:01/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic myelogenous leukemia
• Date of first enrollment: 2009/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Nilotinib will be administered twice daily at a dose of 400 mg (800 mg/day) for 2 year.

Outcome(s)

• Primary Outcome: To assess the rate of major molecular response at 12 months of nilotinib therapy.
• Secondary Outcome: 1) To evaluate the response rates at 12 and 24 months of nilotinib therapy. 2) To evaluate the safety of nilotinib 3) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 3 years.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry. 2) Patients whose clone exhibit the T315I BCR-ABL mutation. 3) Patients who have any cardiac disturbances. 4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.

Related Information

• Primary Sponsor: Shimousa Hematology Study Group
• Source(s) of Monetary Support: Ibaraki Hematology, Oncology & Palliation Expert Meeting(IB-HOPE)