UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033911
Receipt number R000037635
Scientific Title Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data
Date of disclosure of the study information 2018/12/01
Last modified on 2022/01/19 11:58:53

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Basic information

Public title

Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data

Acronym

Analysis of allo-HCT for PIDs in Japan

Scientific Title

Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data

Scientific Title:Acronym

Analysis of allo-HCT for PIDs in Japan

Region

Japan


Condition

Condition

Primary immunodeficiency

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

In order to improve hematopoietic cell transplantation (HCT) for primary immunodeficiencies (PIDs), we clarify the significance, efficacy and the risks of HCT, optimal donor selection, the choice of conditioning regimens, and management guidelines for adverse events by analyzing the data of patients with PIDs who have received HCT in Japan using PIDJ and TRUMP data.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Overall survival/ event-free survival in patients with PID after HCT

Key secondary outcomes

We divide the patients into following subgroups; different periods of years, disease categories according to International Union of Immunological Societies; IUIS classification, pre-HCT status of complications; infection, autoimmune disease or autoinflammatory diseases, conditioning regimen; myeloablative, reduced intensity or nothing, and donor sources. We analyze survival, adverse events and long-term immunological reconstitution (i.e. post-transplant chimerism and secession of immunoglobulin supplementation) in each subgroup.
In addition, we identify the factors contributing to survival by multivariate analysis, as well as the risks for post-HCT adverse events such as graft-versus host disease, infection or the late complications.


Base

Study type

Observational


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

The patients with PID in TRUMP registration who have received HCT from January 1974 to December 2016

Key exclusion criteria

The patients whose TRUMP data are insufficient for analysis.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohiro Morio

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Department of Pediatrics and Developmental Biology

Zip code


Address

Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5249

Email

tmorio.ped@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Miyamoto

Organization

Tokyo Medical and Dental University

Division name

Department of Pediatrics

Zip code


Address

Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5249

Homepage URL


Email

smiyped@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

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 12 Month 01 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

2018 Year 07 Month 24 Day

Date of IRB

2018 Year 07 Month 24 Day

Anticipated trial start date

2018 Year 07 Month 24 Day

Last follow-up date

2018 Year 07 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2018 Year 08 Month 27 Day

Last modified on

2022 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name