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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006294
Receipt No. R000007452
Scientific Title Efficacy of Nilotinib in Patients with Chronic Myeloid Leukemia in chronic phase unachieved Complete Molecular Response
Date of disclosure of the study information 2011/09/06
Last modified on 2016/09/09

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Basic information
Public title Efficacy of Nilotinib in Patients with Chronic Myeloid Leukemia in chronic phase unachieved Complete Molecular Response
Acronym Efficacy of Nilotinib in Patients with CML unachieved CMR
Scientific Title Efficacy of Nilotinib in Patients with Chronic Myeloid Leukemia in chronic phase unachieved Complete Molecular Response
Scientific Title:Acronym Efficacy of Nilotinib in Patients with CML unachieved CMR
Region
Japan

Condition
Condition Chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 CMR rate after Nlotinib treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CMR rate after Nlotinib treatmentat 2-year
Key secondary outcomes The achievement of CMR time after the administration Nlotinib.
CMR rate after Nlotinib treatmentat 1-year.
Correlate trough levels of Nlotinib with clinical response.

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 Nlotinib treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Chronic myelogenous leukemia in chronic-phase and accerated-phase
2)Patients with CML unachieved CMR who treatment 2y by TKI
3)Age &sup3;20 years
4)PS 0-2(ECOG)
5)No severe major organ dysfunction (AST,ALT, creatinine <3.0x ULN)
6) Written informed consent
Key exclusion criteria 1) Patients suspected in AP and BC
2) Pregnant and/or lactating woman
3) Severe psychological disorders
4) Uncontorlled complications
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Okada
Organization Hyogo College of Medicine,
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6886
Email masaya@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Okada
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6886
Homepage URL
Email masaya@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学 血液内科

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
2015 Year 01 Month 01 Day
Date trial data considered complete
2015 Year 01 Month 01 Day
Date analysis concluded
2015 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 06 Day
Last modified on
2016 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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