NIPH Clinical Trials Search

UMIN ID: UMIN000002007

Registered date:01/06/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedChronic myelogenous leukemia
Date of first enrollment2009/05/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Nilotinib will be administered twice daily at a dose of 400 mg (800 mg/day) for 2 year.


Primary OutcomeTo assess the rate of major molecular response at 12 months of nilotinib therapy.
Secondary Outcome1) 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 minimum16years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Kuniaki Itoh
Address 6-5-1 Kashiwanoha Kashiwa, Chiba, 277-8577 Japan Japan
Telephone 04-7133-1111
Affiliation National Cancer Center Hospital East Division of Oncology/Hematology
scientific contact
Name Hisashi Wakita
Address 90-1 Iidacho Narita, Chiba, 286-8523 Japan Japan
Telephone 0476-22-2311
Affiliation Japanese Red Cross Society Narita Hospital Hematology & Oncology