UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004798 |
|---|---|
| Receipt number | R000005694 |
| Scientific Title | Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia |
| Date of disclosure of the study information | 2011/01/05 |
| Last modified on | 2018/01/05 13:59:50 |
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Basic information
Public title
Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia
Acronym
Discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia
Scientific Title
Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia
Scientific Title:Acronym
Discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia
Region
| Japan |
Condition
Condition
Chronic myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of sustained complete molecular response after discontinuation of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia patients who have sustained complete molecular response for over 2 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse of chronic myeloid leukemia after discontinuation of tyrosine kinase inihibitors
Key secondary outcomes
Change in QOL status, reduction of adverse events related to tyrosine kinase inhibitor treatment, reduction of economic burden
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
Discontinuation of tyrosine kinase inhibitor 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) No history of AP/BC while under treatment with TKI
2) Sustained complete molecular response for over 2 years
3) Has given written informed consent
4) Is able to visit the hospital at a pre required time point
Key exclusion criteria
1) Has a history of AP/BC during TKI treatment
2) Cannot give written informed consent
3) Any patient whom the treating physician feels inappropriate for accrual
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3785
okamoto@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Matsuki |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3785
Homepage URL
erie@kk.iij4u.or.jp
Sponsor or person
Institute
Keio University School of Medicine, Division of Hematology
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005694
