UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008653 |
|---|---|
| Receipt number | R000010167 |
| Scientific Title | A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome. |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2018/02/13 18:10:28 |
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Basic information
Public title
A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome.
Acronym
Efficacy of Imatinib for HES
Scientific Title
A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshio Katayama |
Organization
Kobe university hospital
Division name
Division of Hematology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6912
katayama@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Sada |
Organization
Kobe University Graduate School of Medicine,
Division name
Division of Hematology,Department of Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5111(6912)
Homepage URL
akikosad@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Medical School Hospital
Institute
Department
Personal name
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
Address
Tel
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 |
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010167
