Multicenter Phase II Clinical Study on the Safety and Efficacy of Nilotinib in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Major Molecular Response

Not Applicable

• Conditions: Chronic Myelogenous Leukemia

• Registration Number: JPRN-UMIN000005903
• Lead Sponsor: Cooperative study among the East Japan CML Study Group, Shimousa Hematology Study Group, Leukemia Study Group in Mie, Niigata CML Study Group and the NPO Tohoku Hematology Expert Meeting

Brief Summary

Primary Endpoint CMR rate at 24 M was estimated at 44.6% (90%CI 34.7-54.8%). Secondary Endpoints CMR rate at 12 M was estimated at 27.0%(90%CI 18.7-36.3%). Sustained CMR rate at 24 M was estimated at 20.3%(95%CI 11.1-29.4%).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-01
• Study Completion: 2014-12-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients previously treated by tyrosine kinase inhibitors other than imatinib. 2) Patients who are participating in any other clinical trial. 3) Patients with the T315I point mutation of BCR-ABL. 4) Patients with one of the following indicators of cardiovascular dysfunction. i) The QT interval cannot be measured on the ECG ii) Complete left bundle branch block iii) Ventricular pacemaker iv) Congenital QT interval prolongation syndrome or a family history of QT interval prolongation syndrome v) History of or current severe ventricular or atrial tachycardia vi) Clinically significant bradycardia at rest (<50 bpm) vii) History of clinically diagnosed myocardial infarction viii) History of unstable angina within 12 months prior to initiation of the study ix) Other clinically significant cardiovascular complications 5) Patients with another primary malignant tumor. 6) Gastrointestinal dysfunction or diseases that could greatly influence absorption of the study medication. 7) Patients with a history of acute or chronic pancreatitis within 1 year prior to participation to the study. 8) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period. 9) Patients with multiple invasive cancers within 5 years prior to initiation of the study. 10) Patients with other serious or uncontrollable complications. 11) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. 12) Patients with cognitive dysfunction. 13) Other patients whom the investigator considers to be unsuitable for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMR rate at 24 months after the initiation of nilotinib treatment.

Secondary Outcome Measures

Name	Time	Method
1) The rate of patients who have sustained CMR for more than 1 year at 24 months after the initiation of nilotinib treatment. 2) CMR rate at 12 months after the initiation of nilotinib treatment. 3) Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment. 4) Relationship between the time needed to reach CCyR and MMR, the CMR rate at 24 months after the initiation of nilotinib, and the rate of patients sustaining CMR for more than 1 year.