UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029097
Receipt number R000033282
Scientific Title Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy
Date of disclosure of the study information 2017/09/12
Last modified on 2021/09/14 09:35:25

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Basic information

Public title

Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy

Acronym

Identification of HLA haplotype in relapsed tumor cells after haploidentical transplantation

Scientific Title

Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy

Scientific Title:Acronym

Identification of HLA haplotype in relapsed tumor cells after haploidentical transplantation

Region

Japan


Condition

Condition

relpased hematological malignancy after haploidnetical HSCT

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To detect the loss of mismatched haplotype which should have been attacked by donor cells, by the identification of relapsed tumor cells after haploidentical HSCT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

the rate of the loss of mismatched haplotype in tumor cells after relapse

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

The identification of HLA haplotype in relapsed tumor cells after haploidentical HSCT.

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Relapsed patients after haploidentical HSCT for hematological malignancy.

Key exclusion criteria

None.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yoshinobu
Middle name
Last name Kanda

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

330-8503

Address

1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan

TEL

+81-48-647-2111

Email

ycanda-tky@umin.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Kako

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

330-8503

Address

1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan

TEL

+81-48-647-2111

Homepage URL


Email

shinichikako@asahi-net.email.ne.jp


Sponsor or person

Institute

Division of Hematology, Saitama Medical Center, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Leukemia Research Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Jichi Medical University Saitama Medical Center

Address

1-847, Amanuma-cho, Omiya-ku , Saitama-shi, Saitama

Tel

+81-48-647-2111

Email

m.kuroda@jichi.ac.jp


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

2017 Year 09 Month 12 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

Enrolling by invitation

Date of protocol fixation

2017 Year 08 Month 25 Day

Date of IRB

2017 Year 08 Month 25 Day

Anticipated trial start date

2017 Year 08 Month 25 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 11 Day

Last modified on

2021 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033282


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name