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

UMIN ID: UMIN000001927

Registered date:01/05/2009

Basic Information

• Health condition(s) or Problem(s) studied: Chronic myelogenous leukemia
• Date of first enrollment: 2009/04/01
• Target sample size: 50
• 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 1 year.

Outcome(s)

• Primary Outcome: To evaluate the rate of patients with a dose of 800 mg/day at 12 months after starting nilotinib therapy.
• Secondary Outcome: 1) To evaluate the response rates at 6 and 12 months of nilotinib therapy. 2) To evaluate the response rates in imatinib-intolerant patients switched to nilotinib therapy at 6 and 12 months after starting imatinib therapy. 3) To evaluate the percentage of patients complying with the protocol treatment by the optimal dose levels at 6 and 12 months of nilotinib therapy. 4) To evaluate the safety of nilotinib 5) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 2 years.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry. 2) Patients who are receiving treatment with other investigational agents. 3) Patients who exhibit the T315I BCR-ABL mutation. 4) Patients who have any cardiac disturbances. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug. 7) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.

Related Information

• Primary Sponsor: Tokyo STI Study Group
• Source(s) of Monetary Support: None