UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014236 |
|---|---|
| Receipt number | R000016558 |
| Scientific Title | Cell immunotherapy infusing HLA-haploidentical lymphocytes from a family member of non-HSCT donor |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2018/12/17 18:29:11 |
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Basic information
Public title
Cell immunotherapy infusing HLA-haploidentical lymphocytes from a family member of non-HSCT donor
Acronym
HLA-haploidentical lymphocyte infusion from a family member of non-HSCT donor
Scientific Title
Cell immunotherapy infusing HLA-haploidentical lymphocytes from a family member of non-HSCT donor
Scientific Title:Acronym
HLA-haploidentical lymphocyte infusion from a family member of non-HSCT donor
Region
| Japan |
Condition
Condition
Relapsed malignancies or refractory viral diseases after allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of safety and efficacy of lymphocyte infusion
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum tolerable dose of T-cell infusion
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
| Other |
Interventions/Control_1
Cell immunotherapy
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
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Fulfilling the criteria mentioned above. 2. Written consent was obtained.
Key exclusion criteria
1. Acute GVHD Grade II or above. 2. Extensive chronic GVHD. 3. Physician's decision.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Inoue |
Organization
Osaka medical center and research institute for maternal and child health
Division name
Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL
0725-56-1220
pedino@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Sawada |
Organization
Osaka medical center and research institute for maternal and child health
Division name
Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL
0725-56-1220
Homepage URL
asawada@mch.pref.osaka.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Research Organization (ACRO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 06 | 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
| 2013 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016558
