UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006294 |
|---|---|
| Receipt number | 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 | 2021/12/23 09:02:14 |
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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 ³20 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
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
masaya@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 01 | Day |
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
| 2021 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
