UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011971 |
|---|---|
| Receipt number | R000013982 |
| Scientific Title | Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2017/10/09 15:20:31 |
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Basic information
Public title
Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study
Acronym
JALSG-STIM213 Study
Scientific Title
Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study
Scientific Title:Acronym
JALSG-STIM213 Study
Region
| Japan |
Condition
Condition
Chronic Myeloid Leukemia Chronic phase
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate successful of treatment free remission of imatinib discontinuation in patients with chronic myelogenous leukemia in the chronic phase who continued a complete molecular response for at least 2 years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
MMR rate at 12 M after discontinuation of treatment
Key secondary outcomes
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 imatinib
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)MajorBCR-ABL positive CML-CP
2)Imatinib treatment more than for 3 years
3)Sustained CMR more than for 2 years
4)Patients who can attend the clinical study site in accordance with the pre-defined schedule.
5) Written informed consent from the subject (from the legal representative if the subject is under 20 years old).
Criteria after Screeing test
1) confirmed MR4.5 by IS-PCR
Key exclusion criteria
1)Patients with a history of treatment by the other TKI.
2)Patients with a history of hematopoietic stem cell transplantation.
3)Patients who have had blast crisis or accelerated CML.
4) Patients who have lost CMR during imatinib treatment.
5)Patients who have discontined imatinib treatment because of poor adherence.
6)Patients who do not want to re start imatinib after lost of MMR.
7)Other patients whom the investigator considers to be unsuitable for participation in the study.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Takahashi |
Organization
Akita Univ.
Division name
Dept. Hematology
Zip code
Address
1-1-1 Hondo, Akita city, Akita
TEL
018-884-6115
naotot@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Takahashi |
Organization
Akita Univ.
Division name
Dept. Hematology
Zip code
Address
1-1-1 Hondo, Akita city, Akita
TEL
018-884-6115
Homepage URL
http://www.jalsg.jp/
naotot@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.jalsg.jp/clinical-research/now
Publication of results
Published
Result
URL related to results and publications
https://www.springermedizin.de/deeper-molecular-response-is-a-predictive-factor-for-treatment-f/1507
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
| 2013 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013982
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| Registered date | File name |
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