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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009251
Receipt No. R000010865
Scientific Title Prospective observational study of the treatment and prognosis in patients with relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2012/11/02
Last modified on 2018/11/29

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Basic information
Public title Prospective observational study of the treatment and prognosis in patients with relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation.
Acronym JSCT-ATLL12
Scientific Title Prospective observational study of the treatment and prognosis in patients with relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym JSCT-ATLL12
Region
Japan

Condition
Condition Adult T-cell leukemia-lymphoma
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate treatment and prognosis in patients with relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation. (Allo-HSCT)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Survivalat 1 year after relapse
Key secondary outcomes

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
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation.
Key exclusion criteria No
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Kato
Organization Kyushu University
Division name Department of Hematology and Oncology
Zip code
Address Fukuoka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization JSCT
Division name ATLL12-DC
Zip code
Address
TEL
Homepage URL
Email jsct-office@umin.ac.jp

Sponsor
Institute JSCT
Institute
Department

Funding Source
Organization Regional Medicine Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2012 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially 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 Main results already published
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information ATLL

Management information
Registered date
2012 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010865

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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