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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012095
Receipt No. R000014134
Scientific Title Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest (PBSCH)
Date of disclosure of the study information 2013/10/25
Last modified on 2017/04/27

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Basic information
Public title Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest (PBSCH)
Acronym Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest
Scientific Title Multicenter randomized controlled prospective trial in peripheral blood stem cell harvest (PBSCH)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hitoshi Ohto
Organization Fukushima Medical University
Division name Department of Blood Transfusion and Transplantation Immunology
Zip code
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1536
Email hit-ohto@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Ikeda
Organization Fukushima Medical University
Division name Department of Blood Transfusion and Transplantation Immunology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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