UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome.
Title of the study (Brief title)	Efficacy of Imatinib for HES
Region	Japan

Condition
Condition	Hypereosinophilic syndrome, chronic eosinophilic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To assess the efficacy and safety of Imatinib in FIP1L1-PDGFRA (F-P) positive as well as negative chronic eosinophilic leukemia/hypereosinophilic syndrome refractory to any other therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Imatinib responsiveness; complete remission(CR) ratio, time to achievement, time to progression.
Key secondary outcomes	1)Organic dysfunction caused by hepereosinophilia 2)Expression levels and stractual changes of F-P fusion mRNA, and mutational analysis in imatinib resistance 3)Adverse effects of Imatinib

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Imatinib administration at the dose of 100mg/day for 4 weeks. Dose escalation up to 400mg/day according to the hematological response.
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	(1)Diagnosed HES/CEL
Key exclusion criteria	1) Presence of any other active neoplasm 2) Prior anti-leukemic treatment within two weeks. 3) Psychological disorder 4) Hypersensitivity to ingredient of Imatinib 5) Pregnant or nursing women 3) Whom the investigator considered inappropriate to this study
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshio Katayama
Organization	Kobe university hospital
Division name	Division of Hematology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-6912
Email	katayama@med.kobe-u.ac.jp

Public contact
Name of contact person	Akiko Sada
Organization	Kobe University Graduate School of Medicine,
Division name	Division of Hematology,Department of Medicine
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-5111(6912)
Homepage URL
Email	akikosad@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Medical School Hospital
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)

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	神戸大学医学部附属病院 Kobe University Medical School Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 10 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 02 Month 16 Day

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

Management information
Registered date	2012 Year 08 Month 08 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010167