UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phase II Clinical Study on the Safety and Efficacy of Nilotinib in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Major Molecular Response
Title of the study (Brief title)	Switch to Tasigna Trial (STAT1)
Region	Japan

Condition
Condition	Chronic Myelogenous Leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the safety and efficacy of nilotinib in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a major molecular response (MMR) with imatinib.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CMR rate at 24 months after the initiation of nilotinib treatment.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	2 capsules (150 mg) of nilotinib will be taken twice daily (600 mg/day) for 2 years.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with CML-CP under treatment with imatinib. 2) Patients who have never had blast crisis or accelerated CML. 3) Patients in whom MMR was demonstrated by an examination conducted within 1 year prior to registration and who have not reached CMR. 4) Age 16 years or older. 5) Patients with an ECOG performance status of 0-2. 6) Patients who have the following clinical laboratory values: i) Serum bilirubin (T.Bil) <=1.5 X the upper limit of normal for the clinical study site (ULN) ii) AST and ALT <=2.5 X ULN iii) Alkaline phosphatase (ALP) <=2.5 X ULN iv) Serum creatinine (s-Cr) <=3.0 X ULN v) Serum lipase <=1.5 X ULN vi) Potassium (K) >=the lower limit of normal at the clinical study site (LLN) vii) Magnesium (Mg) >=LLN viii) Phosphate (IP) >=LLN ix) Total calcium (Ca) (after adjustment by serum albumin) >=LLN x) QTc <450 msec on ECG 7) Patients who can attend the clinical study site in accordance with the pre-defined schedule. 8) Written informed consent from the subject (from the legal representative if the subject is under 20 years old).
Key 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.
Target sample size	120

Research contact person
Name of lead principal investigator	Naoto Takahashi
Organization	Akita University School of Medicine
Division name	Department of Hematology, Nephrology and Rheumatology
Address	1-1-1 Hondo, Akita, 010-8543, Japan
TEL	018-884-6115
Email	naotot@doc.med.akita-u.ac.jp

Public contact
Name of contact person	Naoto TAKAHASHI
Organization	Akita University School of Medicine
Division name	Department of Hematology, Nephrology and Rheumatology
Address	1-1-1 Hondo, Akita, 010-8543, Japan
TEL	018-884-6115
Homepage URL
Email	naotot@doc.med.akita-u.ac.jp

Sponsor
Institute	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
Institute
Department

Funding Source
Organization	Novartis Pharma K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 31 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2014 Year 12 Month 20 Day
Date of closure to data entry	2015 Year 01 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 01 Day
Date analysis concluded	2015 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs12185-018-2459-6
Results	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%).
Other related information

Management information
Registered date	2011 Year 07 Month 01 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006982