UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group study
Title of the study (Brief title)	JALSG-STIM213 Study
Region	Japan

Condition
Condition	Chronic Myeloid Leukemia Chronic phase
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate successful of treatment free remission of imatinib discontinuation in patients with chronic myelogenous leukemia in the chronic phase who continued a complete molecular response for at least 2 years
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	MMR rate at 12 M after discontinuation of 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	discontinuation of imatinib
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)MajorBCR-ABL positive CML-CP 2)Imatinib treatment more than for 3 years 3)Sustained CMR more than for 2 years 4)Patients who can attend the clinical study site in accordance with the pre-defined schedule. 5) Written informed consent from the subject (from the legal representative if the subject is under 20 years old). Criteria after Screeing test 1) confirmed MR4.5 by IS-PCR
Key exclusion criteria	1)Patients with a history of treatment by the other TKI. 2)Patients with a history of hematopoietic stem cell transplantation. 3)Patients who have had blast crisis or accelerated CML. 4) Patients who have lost CMR during imatinib treatment. 5)Patients who have discontined imatinib treatment because of poor adherence. 6)Patients who do not want to re start imatinib after lost of MMR. 7)Other patients whom the investigator considers to be unsuitable for participation in the study.
Target sample size	62

Research contact person
Name of lead principal investigator	Naoto Takahashi
Organization	Akita Univ.
Division name	Dept. Hematology
Address	1-1-1 Hondo, Akita city, Akita
TEL	018-884-6115
Email	naotot@doc.med.akita-u.ac.jp

Public contact
Name of contact person	Naoto Takahashi
Organization	Akita Univ.
Division name	Dept. Hematology
Address	1-1-1 Hondo, Akita city, Akita
TEL	018-884-6115
Homepage URL	http://www.jalsg.jp/
Email	naotot@doc.med.akita-u.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2013 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 06 Day
Anticipated trial start date	2013 Year 11 Month 30 Day
Last follow-up date	2015 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 07 Month 31 Day

Related information
URL releasing protocol	http://www.jalsg.jp/clinical-research/now
Publication of results	Published
URL releasing results	https://www.springermedizin.de/deeper-molecular-response-is-a-predictive-factor-for-treatment-f/1507
Results
Other related information

Management information
Registered date	2013 Year 10 Month 06 Day
Last modified on	2017 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013982