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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011099
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email shkimu@cc.saga-u.ac.jp

Sponsor
Institute 1st DADI/IMIDAS4th -Trial Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012999

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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