UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025084