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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021750
Receipt No. 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 2017/09/22

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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
Middle name
Last name Tatsuro Jo
Organization Japanese Red Cross Nagasaki Genbaku Hospital
Division name Hematology
Zip code
Address 3-15 Mori-machi, Nagasaki City, Nagasaki Prefecture
TEL 095-847-1511
Email firetj@nagasaki-med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Jo
Organization Japanese Red Cross Nagasaki Genbaku Hospital
Division name Hematology
Zip code
Address 3-15 Mori-machi, Nagasaki City, Nagasaki Prefecture
TEL 095-847-1511
Homepage URL
Email firetj@nagasaki-med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 25 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
2016 Year 04 Month 02 Day
Last modified on
2017 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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