Unique ID issued by UMIN | UMIN000008653 |
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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 |
A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome.
Efficacy of Imatinib for HES
A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome.
Efficacy of Imatinib for HES
Japan |
Hypereosinophilic syndrome, chronic eosinophilic leukemia
Hematology and clinical oncology |
Malignancy
YES
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.
Safety,Efficacy
Imatinib responsiveness; complete remission(CR) ratio, time to achievement, time to progression.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
No treatment
1
Treatment
Medicine |
Imatinib administration at the dose of 100mg/day for 4 weeks. Dose escalation up to 400mg/day according to the hematological response.
20 | years-old | <= |
Not applicable |
Male and Female
(1)Diagnosed HES/CEL
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
30
1st name | |
Middle name | |
Last name | Yoshio Katayama |
Kobe university hospital
Division of Hematology
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
078-382-6912
katayama@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Akiko Sada |
Kobe University Graduate School of Medicine,
Division of Hematology,Department of Medicine
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
078-382-5111(6912)
akikosad@med.kobe-u.ac.jp
Kobe University Medical School Hospital
none
Self funding
NO
神戸大学医学部附属病院 Kobe University Medical School Hospital
2012 | Year | 08 | Month | 15 | Day |
Unpublished
Completed
2007 | Year | 10 | Month | 01 | Day |
2012 | Year | 08 | Month | 10 | Day |
2016 | Year | 09 | Month | 30 | Day |
2017 | Year | 02 | Month | 16 | Day |
2012 | Year | 08 | Month | 08 | Day |
2018 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010167
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