UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phase II Clinical Study of the research on optimal assessments and treatment strategy of nilotinib in newly diagnosed chronic myelogenous leukemia patients in the chronic phase (CML-CP) based on early achievement of complete molecular response (CMR); N-road
Title of the study (Brief title)	N-road trial
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 investigate the safety and efficacy of nilotinib in newly diagnosed chronic myelogenous leukemia patients in the chronic phase (CML-CP) based on early achievement of complete molecular response (CMR)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	The CMR rate by 24 months after the initiation of nilotinib treatment
Key secondary outcomes	* Percentage of patients maintaining CMR for more than 1 year during 24-month nilotinib treatment period * Cumulative CMR rate by 12 and 18 months after the initiation of nilotinib treatment * Cumulative MMR or MR4 rate by 12, 18, and 24 months after the initiation of nilotinib treatment * Cumulative MCyR or CCyR rate by 6 and 12 months after the initiation of nilotinib treatment * OS, PFS, EFS and investigation of prognosis predicting factors * Factors that predict achieving CMR * Safety and tolerability of nilotinib (including treatment continuation rate)

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	Nilotinib (300 mg) is administered twice daily (600 mg/day) for 24 months.In addition, for patients who meet the criteria for no optimal response in this study, nilotinib 400 mg bid (800 mg/day) is initiated as the second-line therapy and is continued for 24 months after the initiation of nilotinib.
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.CML patients whom Ph chromosome was detected by chromosomal analysis (G-band method or FISH method) or BCR-ABL mRNA was detected by RT-PCR method 2.CML patients who were diagnosed within 6 months before the registration to the study 3.Patients who do not suggest the accelerated phase (AP) or blastic phase (BP) CML 4.Age 16 years or older 5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 6.Written informed consent (from the legal representative if the subject is under 20 years old)
Key exclusion criteria	1.Previously treated by tyrosine kinase inhibitors other than imatinib 2.Previously received imatinib for more than 2 weeks 3.Previous treatment experience with IFN-alpha 4.Received oral anticancer drugs such as hydroxyurea for more than 3 months. 5.Confirmed to have the T315I point mutation of BCR-ABL 6.History of hematopoietic stem cell transplantation 7.Patients with cardiovascular dysfunction 8.Other uncontrolled complications. 9.Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
Target sample size	50

Research contact person
Name of lead principal investigator	Hisashi WAKITA
Organization	Japanese Red Cross Society Narita Hospital
Division name	Division of Hematology and Oncology
Address	90-1, Iida-cho, Narita, CHIBA, 286-8523
TEL	0476-22-2311
Email	wakita@naritasekijyuji.jp

Public contact
Name of contact person	Kaichi NISHIWAKI
Organization	Jikei University Kashiwa Hospital
Division name	Department of Oncology and Haematology
Address	163-1, Kashiwashita, Kashiwa, CHIBA, 277-8567
TEL	04-7164-1111
Homepage URL
Email	nishiwaki@jikei.ac.jp

Sponsor
Institute	Cooperative study between Jikei University Kashiwa Hospital and Shimousa Hematology Study Group
Institute
Department

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

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	2012 Year 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 07 Month 18 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2017 Year 07 Month 26 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 10 Month 03 Day
Date analysis concluded	2017 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 30 Day
Last modified on	2018 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010067