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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033198
Receipt No. R000033456
Scientific Title Comparison of outcomes after HLA-haploidentical stem cell transplantation using posttransplantation cyclophosphamide (PTCY) and unrelated allogeneic stem cell transplantation.
Date of disclosure of the study information 2018/06/29
Last modified on 2020/07/29

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Basic information
Public title Comparison of outcomes after HLA-haploidentical stem cell transplantation using posttransplantation cyclophosphamide (PTCY) and unrelated allogeneic stem cell transplantation.
Acronym AMED PTCY 17
Scientific Title Comparison of outcomes after HLA-haploidentical stem cell transplantation using posttransplantation cyclophosphamide (PTCY) and unrelated allogeneic stem cell transplantation.
Scientific Title:Acronym AMED PTCY 17
Region
Japan

Condition
Condition Patients receiving HLA haploidentical stem cell transplantation with posttransplantation cyclophosphamide or unrelated stem cell transplantation.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the outcomes after HLA-haploidentical stem cell transplantation using posttransplantation cyclophosphamide (PTCY) and unrelated allogeneic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retrospective comparative analysis and a decision analysis
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who receive HLA-haploidentical stem cell transplantation or unrelated stem cell transplantation between 2012 and 2015
Key exclusion criteria Not applicable
Target sample size 279

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Teshima
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address N15 W7, Kita-Ku, Sapporo 060-8638
TEL 011-706-7214
Email sugitaj@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Sugita
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address N15 W7, Kita-Ku, Sapporo 060-8638
TEL 011-706-7214
Homepage URL
Email sugitaj@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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
2018 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2017 Year 12 Month 06 Day
Date of IRB
2017 Year 12 Month 06 Day
Anticipated trial start date
2017 Year 12 Month 06 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033456

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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