UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest (PBSCH)
Title of the study (Brief title)	Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest
Region	Japan

Condition
Condition	Hematological malignancies
Classification by specialty	Hematology and clinical oncology Blood transfusion
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	It is to compare efficiency, safety, operation between Spectra-Optia and Spectra-Auto (both from Terumo BCT).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numbers and efficiencies of collected CD34+ cells and mononuclear cells. Contaminated unnecessary cells Frequencies of adverse reactions.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Spectra-Optia will be chosen for peripheral blood stem cell harvest
Interventions/Control_2	Spectra-Auto will be chosen for peripheral blood stem cell harvest
Interventions/Control_3	Spectra-Optia and Spectra-Auto will be chosen for peripheral blood stem cell harvest at first and second days, respectively
Interventions/Control_4	Spectra-Auto and Spectra-Optia will be chosen for peripheral blood stem cell harvest at first and second days, respectively
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will require autologous peripheral blood stem cell transplantation (PBSCT) or donors for allogeneic PBSCT will be eligible if they undergo PBSCH. Written informed consent is required, and enrollees should be 18 years or older.
Key exclusion criteria	Patients or donors without written informed consent will be excluded.
Target sample size	200

Research contact person
Name of lead principal investigator	Hitoshi Ohto
Organization	Fukushima Medical University
Division name	Department of Blood Transfusion and Transplantation Immunology
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1536
Email	hit-ohto@fmu.ac.jp

Public contact
Name of contact person	Kazuhiko Ikeda
Organization	Fukushima Medical University
Division name	Department of Blood Transfusion and Transplantation Immunology
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1536
Homepage URL
Email	kazu-ike@fmu.ac.jp

Sponsor
Institute	Japan Society of Blood Transfusion and Cell Therapy
Institute
Department

Funding Source
Organization	Terumo BCT
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2013 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 17 Day
Anticipated trial start date	2013 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded	2016 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 21 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014134