UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study of the treatment and prognosis in patients with relapsed adult T-cell leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation.
Title of the study (Brief title)	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	Koji Kato
Organization	Kyushu University
Division name	Department of Hematology and Oncology
Address	Fukuoka, Japan
TEL
Email

Public contact
Name of contact person
Organization	JSCT
Division name	ATLL12-DC
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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