UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029534
Receipt No. R000033733
Scientific Title Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2
Date of disclosure of the study information 2017/10/13
Last modified on 2020/04/22 (Ver. 9)

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Basic information
Public title Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2
Acronym STOP FN in NHL 2
Scientific Title Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2
Scientific Title:Acronym STOP FN in NHL 2
Region
Japan

Condition
Condition Non Hodgkin's Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determine the incidence of FN in NHL patients receiving (R)CHOP regimen. Explore the risk factors of FN in (R)CHOP regimen treated NHL patients by analyzing the relationship between FN and patient background factors.
Examine the incidence of hospitalization due to FN and the use of antibiotics.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of FN during the 1st cycle of chemotherapy in NHL patients
Key secondary outcomes

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 NHL patients received (R)CHOP regimen
Key exclusion criteria HIV related NHL
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kiyohiko
Middle name
Last name Hatake
Organization The Cancer Institute Hospital Of JFCR
Division name Hematological Oncology Department
Zip code 135-8550
Address 3-8-31, Ariake, Koto, Tokyo
TEL 03-3520-0111
Email khatake@jfcr.or.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Nukada
Organization Kyowa Kirin
Division name Medical Affairs
Zip code 100-0004
Address 1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL 03-5205-7200
Homepage URL
Email ma.oncology@kyowa-kirin.co.jp

Sponsor
Institute The Cancer Institute Hospital Of JFCR
Institute
Department

Funding Source
Organization Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Cancer Institute Hospital Japanese Foundation For Cancer Research
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
Tel 03-3520-0111
Email med.shinsa@jfcr.or.jp

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 13 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications https://rd.springer.com/article/10.1007/s00520-019-04802-4
Number of participants that the trial has enrolled 239
Results 
Refer to the article
Results date posted
2020 Year 04 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Non Hodgkin's Lymphoma
Participant flow 
A total of 239 patients were evaluated and the most common pathological diagnosis was diffuse large B cell lymphoma.
Adverse events 
None
Outcome measures 
Incidence of FN during the 1st cycle of chemotherapy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 18 Day
Date of IRB
2017 Year 10 Month 05 Day
Anticipated trial start date
2017 Year 10 Month 16 Day
Last follow-up date
2018 Year 01 Month 26 Day
Date of closure to data entry
2018 Year 02 Month 20 Day
Date trial data considered complete
2018 Year 03 Month 26 Day
Date analysis concluded
2019 Year 11 Month 12 Day

Other
Other related information Retrospective observational study.

Management information
Registered date
2017 Year 10 Month 13 Day
Last modified on
2020 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033733