UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008565 |
|---|---|
| Receipt number | R000010067 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2018/08/07 21:01:19 |
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Basic information
Public title
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
Acronym
N-road trial
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hisashi WAKITA |
Organization
Japanese Red Cross Society Narita Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
90-1, Iida-cho, Narita, CHIBA, 286-8523
TEL
0476-22-2311
wakita@naritasekijyuji.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaichi NISHIWAKI |
Organization
Jikei University Kashiwa Hospital
Division name
Department of Oncology and Haematology
Zip code
Address
163-1, Kashiwashita, Kashiwa, CHIBA, 277-8567
TEL
04-7164-1111
Homepage URL
nishiwaki@jikei.ac.jp
Sponsor or person
Institute
Cooperative study between Jikei University Kashiwa Hospital and Shimousa Hematology Study Group
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 07 | Month | 18 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010067
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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