UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015736 |
|---|---|
| Receipt number | R000018313 |
| Scientific Title | Allogeneic hematopoietic stem cell transpalntation using Thymoglobulin for patients with T-cell malignancy |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2018/10/31 16:51:17 |
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Basic information
Public title
Allogeneic hematopoietic stem cell transpalntation using Thymoglobulin for patients with T-cell malignancy
Acronym
AlloHSCT with ATG for T-cell malignancy
Scientific Title
Allogeneic hematopoietic stem cell transpalntation using Thymoglobulin for patients with T-cell malignancy
Scientific Title:Acronym
AlloHSCT with ATG for T-cell malignancy
Region
| Japan |
Condition
Condition
T-cell malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of allogeneic HSCT using Thymoglobulin against T-cell malignancy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Probability of survival with engraftment at 60 days after allogeneic HSCT
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conditioning regimen using Thymoglobulin
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) HSCT using a HLA matched related donor, or HLA at least 6/8 matched unrelated donor
(2) T-cell malignancy, including B-cell lymphoma expressing T cell marker
(3) Disease status no complete remission
(4) 18<=age<=70
(5) ECOG PS 0 or 1
(6) informed consent
(7) those who are expected to survive at least 3 months
Key exclusion criteria
(1) severe organ failure
(2) uncontrolled hypertension
(3) HIV infection
(4) uncontrolled active infection
(5) uncontrolled CNS invasion
(6) pregnancy
(7) psychological disorder
(8) allergy to drugs used in this study
(9) if the physician consider as inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Division of Hematopoietic Stem Cell Transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
sfuji@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Division of Hematopoietic Stem Cell Transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
sfuji@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 11 | Month | 21 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018313
