UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009251 |
|---|---|
| Receipt number | 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 11:42:14 |
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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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
JSCT
Division name
ATLL12-DC
Zip code
Address
TEL
Homepage URL
jsct-office@umin.ac.jp
Sponsor or person
Institute
JSCT
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010865
