UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021750 |
|---|---|
| Receipt number | R000025084 |
| Scientific Title | A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2020/09/17 11:12:48 |
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Basic information
Public title
A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma
Acronym
A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma
Scientific Title
A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma
Scientific Title:Acronym
A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma
Region
| Japan |
Condition
Condition
Adult T-cell leukemia/lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We inspect whether varicella zoster virus (VZV) vaccine inoculation can induce anti-HTLV-I specific cytotoxic T lymphocytes (CTL) in ATLL patients undergoing chemotherapy including Mogamulizumab, and also the safety of VZV vaccine inoculation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether VZV vaccine inoculation can induce anti-HTLV-I specific CTL or not?
Key secondary outcomes
The safety assessment of adverse events, such as herpes zoster, induced by VZV vaccine inoculation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
VZV vaccine
Interventions/Control_2
Combination chemotherapy including Mogamulizumab
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.HTLV-I antibody is positive. The diagnosis is made as a peripheral lymphoid tumor cytologically or histopathologically, and the tumor is proved to be of T-cell origin by surface marker.
2.CCR4 antigen of the tumor is positive in flow cytometric analysis or immunohistochemical analysis.
3.An anti-VZV antibody [IAHA or EIA (IgG)] is positive (more than 4 times) before VZV vaccine inoculation.
4.It is confirmed before VZV vaccine inoculation that cellular immunocompetence of patients is enough (with positive results of lymphocyte stimulation test for PHA and Con-A).
5.The patients have HLA type A*02:01 or A*24:02.
6.To enroll the patients that Moga alone or Moga + chemotherapy has been already started is permitted.
7.The patients 20 years or older can be enrolled.
Key exclusion criteria
1.In the case of an infectious disease due to a virus belonging to Herpesviridae before inoculation of VZV vaccine after the initiation of chemotherapy for ATLL.
2.In the case that the patient has another active primary cancer.
3.In the case that HBs antigen is positive.
4.In the case that HIV antibody is positive.
5.Women during pregnancy. Women of lactating.
6.In the case that the patient is complicated with psychosis or psychiatric symptoms, and it is judged that the enrollment of the study is difficult.
7.In the case that the patient has a disease, which is not ATLL, with the immunodeficiency or the immunosuppression. In the case that the patient receives an immunosuppressive therapy.
8.In the case that the patient is judged to be unsuitable for a trial entry by the medical attendant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Jo |
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Hematology
Zip code
852-8511
Address
3-15 Mori-machi, Nagasaki City, Nagasaki Prefecture
TEL
095-847-1511
firetj@nagasaki-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Jo |
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Hematology
Zip code
852-8511
Address
3-15 Mori-machi, Nagasaki City, Nagasaki Prefecture
TEL
095-847-1511
Homepage URL
firetj@nagasaki-med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department
Personal name
Funding Source
Organization
The Research Foundation for Microbial Diseases of Osaka University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
The Research Foundation for Microbial Diseases of Osaka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051180107
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Funding Source and Co-sponsor: The Research Foundation for Microbial Diseases of Osaka University (supported from Mar 27, 2018 to Dec 31, 2019)
Management information
Registered date
| 2016 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025084
