UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Efficacy of G-CSF 'filgrastim BS' administration in the peripheral blood stem cell (PBSC) mobilization
Title of the study (Brief title)	Safety and Efficacy of filgrastim BS in the PBSC mobilization
Region	Japan

Condition
Condition	Related donors for allogeneic PBSC transplantation
Classification by specialty	Hematology and clinical oncology Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the safety and efficacy of the G-CSF 'filgrastim BS' administration in the PBSC mobilization
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Adverse events during the PBSC mobilization 2. Efficacy of the PBSC mobilization
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Subcutaneous administration of filgrastim BS 300mcg twice daily on days 1-4 and one dose on day 5. Complete blood count is carried out on days 1-5. PBSCs are harvested on days 4 and 5.
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	16 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Give informed consent for the PBSC mobilization by G-CSF administration. 2. Enroll in the accident insurance for the PBSC mobilization. 3. Give informed consent for the current study, approved by the institutional ethics comittee.
Key exclusion criteria	In case the attending physician judge the candidate not suitable for this study.
Target sample size	20

Research contact person
Name of lead principal investigator	NAKAO, Shinji
Organization	Kanazawa University Hospital
Division name	Hematology
Address	13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL	076-265-2274
Email	snakao8205@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	KUBOTA, Chizuru
Organization	Kanazawa University Hospital
Division name	Hematology
Address	13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL	076-265-2275
Homepage URL
Email	ckubota@staff.kanazawa-u.ac.jp

Sponsor
Institute	Div. Hematology and Div. Transfusion Medicine, Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Fuji Pharma 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	YES
Study ID_1	2013-038
Org. issuing International ID_1	Innovative Clinical Research Center, Kanazawa University Hospital
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 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2013 Year 12 Month 26 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 11 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017573