Unique ID issued by UMIN | UMIN000037105 |
---|---|
Receipt number | R000042224 |
Scientific Title | Integrated Three Japanese Institution's Experience of Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma Treated with Yittrium 90 Ibritumomab Tiuxetan (Zevalin): Factors Associated with Long-Term Responses |
Date of disclosure of the study information | 2019/06/19 |
Last modified on | 2023/06/22 09:37:19 |
Integrated Three Japanese Institution's Experience of Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma Treated with Yittrium 90 Ibritumomab Tiuxetan (Zevalin): Factors Associated with Long-Term Responses
J3Zi Study
Integrated Three Japanese Institution's Experience of Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma Treated with Yittrium 90 Ibritumomab Tiuxetan (Zevalin): Factors Associated with Long-Term Responses
J3Zi Study
Japan |
B-Cell Non-Hodgkin Lymphoma
Hematology and clinical oncology |
Malignancy
NO
Integrate three Japanese institution (National Hospital Organization Kyushu Cancer Center, Hyogo College Of Medicine College Hospital, Kansai Medical University Hospital) data regarding the relapsed or refractory indolent B-Cell Non-Hodgkin lymphoma treated with Yittrium 90 Ibritumomab Tiuxetan (Zevalin): and investigate the factors associated with long-term responses using overall survival (OS) and progression-free survival; (PFS)
Safety,Efficacy
Others
Others
Not applicable
1) Progression-free survival (PFS)median time after Zevalin treatment
2) Overall survival (OS)meedian time after Zevalin treatment
3) Two years PFS after Zevalin treatment
4) Five years OS after Zevalin treatment
Efficacy:
1) Five years PFS after Zevalin treatment
2) One year PFS after Zevalin treatment
3) Two years OS after Zevalin treatment
4) One year OS after Zevalin treatment
Safety:
1) Occurrence rate of hematological toxicity grade >=3 within 12 weeks after Zevalin treatment
2) Occurrence rate of hematological toxicity grade >=4 within 12 weeks after Zevalin treatment
3) With or without hematological treatment (platelet blood transfusion, red blood cell transfusion, C-GSF treatment) within 12 weeks after Zevalin treatment
4) With or without infection disease treatment within one year after Zevalin treatment
5) Occurrence rate of subsequent neoplasms (t-MDS/AML) in patient follow-up more than 2 years
Observational
Not applicable |
Not applicable |
Male and Female
1 Neutrophil count >= 1.2x109/L
2 Platelet count >= 100x109/L
3 Bone marrow infiltration rate < 25%
4 Zevalin treatment date before 2018/5/31 (in attempt to be more than one year of follow-up )
1 No efficacy evaluation of Zevalin treatmen using PET or CT
2 No follow-up after Zevalin treatment
320
1st name | Ilseung |
Middle name | |
Last name | Choi |
National Hospital Organization Kyushu Cancer Center
Hematology
811-1395
3-1-1, Notame, Minami-ku, Fukuoka-shi, Fukuoka
0925413231
choi.ilseung.yc@mail.hosp.go.jp
1st name | Takehisa |
Middle name | |
Last name | Yamamoto |
Sagano Co., Ltd.
Science Support Planning Division
169-0075
3-23-7, Takadanobaba, Shinjuku-ku, Tokyo
0353387654
takehisa.yamamoto@saganocorp.jp
Sagano Co., Ltd.
Science Support Planning Division
Mundipharma Co., Ltd.
Profit organization
Japan
Iryo hojin shadan Tokei-kai kitamachi shinryo-sho rinri shinsa iin-kai
1-1-3, Kichijojikitamachi, Musashino-shi, Tokyo
07050118550
shingo-namiki@j-smo.com
NO
独立行政法人国立病院機構 九州がんセンター (福岡県)
National Hospital Organization Kyushu Cancer Center
兵庫医科大学病院(兵庫県)
Hyogo College Of Medicine College Hospital
関西医科大学付属病院(大阪府)
Kansai Medical University Hospital
2019 | Year | 06 | Month | 19 | Day |
Nothing
Unpublished
Nothing
316
Currently writing a dissertation
2021 | Year | 12 | Month | 28 | Day |
Patients with CD20-positive relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL)
Omitted for retrospective exam
Writing a dissertation
Data from three domestic facilities (Kyushu Cancer Center, Hyogo College of Medicine Hospital, and Kansai Medical University Hospital) for zevalin treatment for relapsed / refractory low-grade B-cell lymphoma were merged to obtain overall survival (OS). Investigate the factors that influence progression-free survival (PFS).
Completed
2019 | Year | 05 | Month | 09 | Day |
2019 | Year | 03 | Month | 19 | Day |
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 08 | Month | 31 | Day |
2023 | Year | 06 | Month | 19 | Day |
2023 | Year | 06 | Month | 19 | Day |
2023 | Year | 06 | Month | 19 | Day |
Multicenter joint backward observation research
2019 | Year | 06 | Month | 19 | Day |
2023 | Year | 06 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042224
Research Plan | |
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Registered date | File name |
2021/02/02 | Fix【兵庫医科大学病院】J3Zi施設別研究計画書v1.docx |
Research case data specifications | |
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Registered date | File name |
2021/02/02 | Fix【3施設共通】J3Zi解析計画書.docx |
Research case data | |
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Registered date | File name |
2023/06/22 | 076abe1f-3b7c-473a-97ea-04fb6685a97a.pdf |