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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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