UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011099 |
|---|---|
| Receipt number | R000012999 |
| Scientific Title | DAsatinib DIscontinuation for 1st-Line treatment with Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission |
| Date of disclosure of the study information | 2013/07/21 |
| Last modified on | 2013/07/02 20:07:20 |
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Basic information
Public title
DAsatinib DIscontinuation for 1st-Line treatment with Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission
Acronym
1st DADI-Trial
Scientific Title
DAsatinib DIscontinuation for 1st-Line treatment with Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission
Scientific Title:Acronym
1st DADI-Trial
Region
| Japan |
Condition
Condition
chronic myeloid leukemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is molecular relapse free survival rate after discontinuation of dastinib in patients with 1st line treatment with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year.
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 dastinib at 6 months.
Key secondary outcomes
Molecular relapse free survival rate after discontinuation of dastinib at 12 months.
We assessed LGL expansions, dose of dasatinib and time to CMR, total dose of dasatinib in last 12 months during CMR, metods and, sex and sokal risk group as potential prognostic factors for molecular relapse free survival.
Molecular remission rate after dasatinib re-challenge in cases of molecular relapse.
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 dastinib in patients with 1st line treatment with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who has been treated by Dasatinib as 1st line treatment at least 24 months with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 1 year.
2. ECOG performance status (PS) score 0-2
3. Adequate hepatic, renal and lung function
4. Signed written informed consent
Key exclusion criteria
1.Patients who have been treated by TKI except Dasatinib or Interferon.(except patients who have treated by Imatinib within 4 weeks as an ex-treatment.)
2. Concurrent malignancy other than CML
3.Women who are pregnant or breastfeeding
4.A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kimura |
Organization
1st DADI/IMIDAS4th -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
1st DADI/IMIDAS4th -Trial Group
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
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 | 07 | Month | 21 | 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 | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 21 | 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
| 2013 | Year | 07 | Month | 02 | Day |
Last modified on
| 2013 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012999
