UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy
Acronym	Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation
Scientific Title	Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy
Scientific Title:Acronym	Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation
Region	Japan

Condition
Condition	Chronic Phase Chronic Myelogenous Leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is designed to evaluate the efficacy and safety of dasatinib treatment and its discontinuation in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who achieved a complete molecular response (CMR) during imatinib therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CMR rate at 12 months after discontinuation of dasatinib 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	Dasatinib will be administered at 100 mg once daily for 24 months and then discontinue dasatinib therapy
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic phase chronic myeloid leukemia who has been reached complete molecular response with imatinib treatment
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
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Eriko Middle name Last name Sato
Organization	Juntendo University School of Medicine
Division name	Department of Hematology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL	03-3813-3111
Email	ersato@juntendo.ac.jp

Public contact
Name of contact person	1st name Eriko Middle name Last name Sato
Organization	Juntendo University School of Medicine
Division name	Department of Hematology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	ersato@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	None
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	Juntendo University School of Medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel	03-5802-1584
Email	chiken@juntendo.ac.jp

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	2012 Year 02 Month 03 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	Completed
Date of protocol fixation	2012 Year 01 Month 28 Day
Date of IRB	2012 Year 01 Month 27 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2030 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2012 Year 02 Month 03 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008503