UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012472 |
|---|---|
| Receipt number | R000014601 |
| Scientific Title | Imatinib discontinuation for Chronic Myelogenou Leukemia-Chronic Phase with 2 years complete molecular remission. |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2013/12/03 14:19:55 |
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Basic information
Public title
Imatinib discontinuation for Chronic
Myelogenou Leukemia-Chronic Phase with 2 years complete molecular remission.
Acronym
Delightedly Overcome CML Expert Stop TKI Trial
(DOMEST Trial)
Scientific Title
Imatinib discontinuation for Chronic
Myelogenou Leukemia-Chronic Phase with 2 years complete molecular remission.
Scientific Title:Acronym
Delightedly Overcome CML Expert Stop TKI Trial
(DOMEST Trial)
Region
| Japan |
Condition
Condition
Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is molecular relapse free survival rate after discontinuation of Imatinib in patients with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Molecular relapse free survival rate after discontinuation of Imatinib at 6 months.
Key secondary outcomes
Molecular relapse free survival rate after discontinuation of Imatinib at 12,24 months.
We assessed previous interferon therapy, sex , sokal risk group and total duration of Imatinib treatment as potential prognostic factors for molecular relapse free survival.
CMR rate and time to CMR of PCR+ patients by PCR screening after dasatinib treatment.
CMR rate and time to CMR of dasatinib treatment after molecular relapse.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Discontinuation of Imatinib in patients with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
Interventions/Control_2
Dasatinib treatment to PCR+ patients by PCR screening.
Interventions/Control_3
Dasatinib treatment to molecular relapse patients during discontinuation Imatinib treatment.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
2. ECOG performance status (PS) score 0-2
3. Adequate hepatic, renal and lung function
4. Signed written informed consent
Key exclusion criteria
1. Concurrent malignancy other than CML
2.Women who are pregnant or breastfeeding
3. A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
4.Subjects with clonal evolution
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kimura |
Organization
Saga Univ, Faculty of Medicine
Division name
Division of Hematology, Respiratory Medicine and Oncology
Zip code
Address
5-1-1 Nabeshima Saga
TEL
0952-34-2353
shkimu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kimura |
Organization
DOMEST-Trial Group
Division name
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga Univ.
Zip code
Address
5-1-1 Nabeshima Saga
TEL
0952-34-2353
Homepage URL
shkimu@cc.saga-u.ac.jp
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
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
佐賀大学医学部（佐賀県）Faculty of Medicine, Saga Univ.
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 04 | 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
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2013 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014601
