UMIN-CTR Clinical Trial

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

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Basic information

Public 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

Acronym

J3Zi Study

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

Scientific Title:Acronym

J3Zi Study

Region

Japan


Condition

Condition

B-Cell Non-Hodgkin Lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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 )

Key exclusion criteria

1 No efficacy evaluation of Zevalin treatmen using PET or CT
2 No follow-up after Zevalin treatment

Target sample size

320


Research contact person

Name of lead principal investigator

1st name Ilseung
Middle name
Last name Choi

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Hematology

Zip code

811-1395

Address

3-1-1, Notame, Minami-ku, Fukuoka-shi, Fukuoka

TEL

0925413231

Email

choi.ilseung.yc@mail.hosp.go.jp


Public contact

Name of contact person

1st name Takehisa
Middle name
Last name Yamamoto

Organization

Sagano Co., Ltd.

Division name

Science Support Planning Division

Zip code

169-0075

Address

3-23-7, Takadanobaba, Shinjuku-ku, Tokyo

TEL

0353387654

Homepage URL


Email

takehisa.yamamoto@saganocorp.jp


Sponsor or person

Institute

Sagano Co., Ltd.
Science Support Planning Division

Institute

Department

Personal name



Funding Source

Organization

Mundipharma Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iryo hojin shadan Tokei-kai kitamachi shinryo-sho rinri shinsa iin-kai

Address

1-1-3, Kichijojikitamachi, Musashino-shi, Tokyo

Tel

07050118550

Email

shingo-namiki@j-smo.com


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

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


Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 19 Day


Related information

URL releasing protocol

Nothing

Publication of results

Unpublished


Result

URL related to results and publications

Nothing

Number of participants that the trial has enrolled

316

Results

Currently writing a dissertation

Results date posted

2021 Year 12 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with CD20-positive relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL)

Participant flow

Omitted for retrospective exam

Adverse events

Writing a dissertation

Outcome measures

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).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 05 Month 09 Day

Date of IRB

2019 Year 03 Month 19 Day

Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 06 Month 19 Day

Date trial data considered complete

2023 Year 06 Month 19 Day

Date analysis concluded

2023 Year 06 Month 19 Day


Other

Other related information

Multicenter joint backward observation research


Management information

Registered date

2019 Year 06 Month 19 Day

Last modified on

2023 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042224


Research Plan
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
Registered date File name
2021/02/02 Fix【3施設共通】J3Zi解析計画書.docx

Research case data
Registered date File name
2023/06/22 076abe1f-3b7c-473a-97ea-04fb6685a97a.pdf