UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study Of Patient risk factors for Febrile Neutropenia in NHL patients receiving (R)CHOP regimen
Title of the study (Brief title)	STOP FN in NHL
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.
Basic objectives2	Others
Basic objectives -Others	Incidence of FN in HNL patients
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

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 HNL
Target sample size	400

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

Public contact
Name of contact person	tomoyuki nukada
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Medical Affairs
Address	1-9-2, Ohtemachi, Chiyoda-ku, Tokyo, Japan
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 Hakko 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)

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	2014 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 15 Day
Anticipated trial start date	2014 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://rd.springer.com/article/10.1007/s00520-017-3747-z
Results	Refer to the article
Other related information	Retrospective research of FN incidence in NHL patients

Management information
Registered date	2014 Year 09 Month 11 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017588