UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002134 |
|---|---|
| Receipt number | R000002415 |
| Scientific Title | Immunotherapy with NK cells |
| Date of disclosure of the study information | 2009/07/08 |
| Last modified on | 2009/06/29 11:50:02 |
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Basic information
Public title
Immunotherapy with NK cells
Acronym
Immunotherapy with NK cells
Scientific Title
Immunotherapy with NK cells
Scientific Title:Acronym
Immunotherapy with NK cells
Region
| Japan | Asia(except Japan) |
Condition
Condition
Clinical study to investigate safety and efficacy on NK cells to health and cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety,Efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Key secondary outcomes
Antitumor effect
Progression-free survival
Overall survival
QOL
Immunological responses
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
To investigate safety and efficacy on NK cells for human
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
| 5 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.5 years or more
2.performance status is 0-1
3.No serious abnormality in bone marrow, liver and/or
renal functions
Key exclusion criteria
1.Uncontrollable infection
2.Serious cardiac disease
3.Active autoimmune disease
4.Pulmonary fibrosis or interstitial pneumonia, or their history, or predisposition to them
5.Serious drug allergy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | zhang benning |
Organization
Harbin Medical University
Division name
Department of Immunology
Zip code
Address
157 baojian-road,harbin city, china
TEL
86-13030028668
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | zhang benning |
Organization
Harbin Medical University
Division name
Department of Immunology
Zip code
Address
157 baojian-road, harbin city, china
TEL
86-13030028668
Homepage URL
zbn-tky@umin.ac.jp
Sponsor or person
Institute
Kuramae clinic
Institute
Department
Personal name
Funding Source
Organization
Kuramae clinic
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 07 | Month | 08 | 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
Date of protocol fixation
| 2007 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 29 | Day |
Last modified on
| 2009 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002415
