UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012095 |
|---|---|
| Receipt number | 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 10:20:39 |
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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
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
kazu-ike@fmu.ac.jp
Sponsor or person
Institute
Japan Society of Blood Transfusion and Cell Therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014134
