UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia
Title of the study (Brief title)	Discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia
Region	Japan

Condition
Condition	Chronic myeloid leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of sustained complete molecular response after discontinuation of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia patients who have sustained complete molecular response for over 2 years.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse of chronic myeloid leukemia after discontinuation of tyrosine kinase inihibitors
Key secondary outcomes	Change in QOL status, reduction of adverse events related to tyrosine kinase inhibitor treatment, reduction of economic burden

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 tyrosine kinase inhibitor treatment
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) No history of AP/BC while under treatment with TKI 2) Sustained complete molecular response for over 2 years 3) Has given written informed consent 4) Is able to visit the hospital at a pre required time point
Key exclusion criteria	1) Has a history of AP/BC during TKI treatment 2) Cannot give written informed consent 3) Any patient whom the treating physician feels inappropriate for accrual
Target sample size	70

Research contact person
Name of lead principal investigator	Shinichiro Okamoto
Organization	Keio University School of Medicine
Division name	Division of Hematology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3785
Email	okamoto@a7.keio.jp

Public contact
Name of contact person	Eri Matsuki
Organization	Keio University School of Medicine
Division name	Division of Hematology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3785
Homepage URL
Email	erie@kk.iij4u.or.jp

Sponsor
Institute	Keio University School of Medicine, Division of Hematology
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 01 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 11 Month 26 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 27 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005694