Unique ID issued by UMIN | UMIN000035121 |
---|---|
Receipt number | R000039806 |
Scientific Title | Efficacy and Safety of Ruxolitinib single treatment in patients with chronic active Epstein-Barr virus infection (Phase II) (investigator-initiated study) |
Date of disclosure of the study information | 2018/12/15 |
Last modified on | 2022/12/05 11:10:06 |
Efficacy and Safety of Ruxolitinib single treatment in patients with chronic active Epstein-Barr virus infection (Phase II) (investigator-initiated study)
Efficacy and Safety of Ruxolitinib for CAEBV patients (Phase II)
Efficacy and Safety of Ruxolitinib single treatment in patients with chronic active Epstein-Barr virus infection (Phase II) (investigator-initiated study)
Efficacy and Safety of Ruxolitinib for CAEBV patients (Phase II)
Japan |
chronic active Epstein-Barr virus infection
CAEBV
Hematology and clinical oncology |
Others
NO
To investigate efficacy and safety of ruxolitinib, JAK1/2 inhibitor, as single treatment for patients with chronic active Epstein-Barr virus infection.
Safety,Efficacy
Exploratory
Phase II
Percentage of participants with complete response (CR) at week 8 or early termination.
Percentage of participants with complete response (CR) at week 4.
Overall response rate at week 8 or early termination.
Adverse event.
Plasma drug concentration.
Epstein-Barr virus DNA quantification .
Plasma cytokine concentration.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
ruxolitinib tablet
13 | years-old | <= |
Not applicable |
Male and Female
Subjects diagnosed as CAEBV under "Guidelines for Clinical Practice for Chronic Active EB Virus Infection and Related Diseases 2016" and matched all criteria below;
(1) with >= 1x10^2.5 copies/mcg DNA of EBV DNA load in peripheral blood measured within 8 weeks prior to registration (only the central measuring institution are acceptable).
(2) with confirmed EBV infection on T- or NK-cells in tissue lesions or in peripheral blood.
(3) with >= 3 months of either continuous or intermittent systemic inflammatory symptoms: persistent fever, liver dysfunction, multiple lymphadenopathy, progressive skin lesions, vasculitis, neuritis, uveitis, enteritis etc. However, subjects with hypersensitivity to mosquito bites and Hydroa Vacciniforme-like eruptions without sustained systemic inflammatory symptoms are not diagnosed with CAEBV and excluded.
(4) negative for the following diseases:
Congenital or acquired immunodeficiency, autoimmune/inflammatory disease, connective tissue disease, malignant lymphoma, leukemia, iatrogenic immunodeficiency.
(5) having active disease during observation period: having fever and/or liver dysfunction defined below.
1) having fever without any other causes (>= 37.5 deg. of axillary temperature) in >= 2 days during 5-day observation.
2) having liver dysfunction defined as increase of ALT levels to two times higher than the upper limit of normal on at least two consecutive occasions.
ALT should be measured twice within 28 days before registration, and both should match the criteria. The latter measurement should be performed within 7 days before registration.
(6) with life expectancy of >= 3 months.
(7) fulfilling the following cell count in peripheral blood in the latest examination within 7 days before registration.
1) >= 500/microL of Neutrophil
2) >= 50,000/microL of Platelet
(8) 13 years of age or older at obtaining informed consent.
(9) who obtained written informed consent from the subjects themselves or legal representative.
Subjects matched any of the followings are excluded;
(1) pathological or clinical lymphoid neoplasm derived from EBV-infected T- or NK-cells of CAEBV.
(2) anti-VCA-IgM Ab positive (difficult to distinguish from infectious mononucleosis).
(3) with history taking JAK 1/2 inhibitors.
(4) with malignant neoplasm or history of them within the last 5 years, though cervical intraepithelial carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin treated properly, fully resected gastric intramucosal carcinoma can be accepted.
(5) with unstoppable treatment with >200 mg/day fluconazole or strong CYP3A4 inducer (rifampicin, St. John's wart etc) at the beginning of study drug administration (excl. topical).
(6) with infectious diseases requiring systemic antibiotics or antivirals.
(7) with tuberculosis or HIV-positive.
(8) with active hepatitis matching any of the following within 84 days before registration;
-HBs Ag-positive
-HBc Ab-positive or HBs Ab-positive with >= 20 IU/mL (1.3 Log IU/mL, the same below) of peripheral blood HBV DNA load
HBs Ag-negative, HBs Ab-positive, HBc Ab-negative and history of the vaccination for HBV are treated as uninfected ones.
-HCV Ab-positive (except when confirmed HCV-RNA-negative).
* There are some conditions for judgment of HBV infection.
(9) with cardiac disease of NYHA class IV.
(10) having been treated with other anticancer drug (e.g. etoposide) within 14 days prior to registration.
(11) with history of hypersensitivity to ingredients of ruxolitinib tablet.
(12) having been treated with another investigational medication within 12 weeks prior to registration.
(13) female who are pregnant, have possibility of pregnancy, or are currently breastfeeding.
(14) difficult to take oral tablet.
(15) judged unsuitable for participation by investigator or sub-investigator.
10
1st name | Ayako |
Middle name | |
Last name | Arai |
St. Marianna University School of Medicine
Department of Hematology and Oncology
216-8511
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
044-977-8111
ara.hema@tmd.ac.jp
1st name | Yuki |
Middle name | |
Last name | Ohta |
St. Marianna University School of Medicine
Center for Clinical and Translational Science
216-8511
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
044-977-8111
mariadc_caebv@marianna-u.ac.jp
St. Marianna University School of Medicine
Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
St. Marianna University Group Institutional Review Board
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
044-977-8111
chikenjimu@marianna-u.ac.jp
YES
TMD18-HEMA-201
Tokyo Medical and Dental University
東京医科歯科大学医学部附属病院(東京都)
大阪母子医療センター(大阪府)
聖マリアンナ医科大学病院(神奈川県)
九州大学病院(福岡県)
2018 | Year | 12 | Month | 15 | Day |
Unpublished
9
Completed
2018 | Year | 11 | Month | 07 | Day |
2018 | Year | 11 | Month | 27 | Day |
2019 | Year | 01 | Month | 09 | Day |
2022 | Year | 03 | Month | 31 | Day |
2018 | Year | 12 | Month | 03 | Day |
2022 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039806