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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032992
Receipt No. R000037618
Scientific Title A clinical study to inspect whether live attenuated VZV vaccine inoculation induces antitumor immunity in patients with CML and patients with MDS
Date of disclosure of the study information 2018/06/14
Last modified on 2019/04/19

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Basic information
Public title A clinical study to inspect whether live attenuated varicella zoster virus (VZV) vaccine inoculation induces antitumor immunity in patients with chronic myelogenous leukemia (CML) and patients with myelodysplastic syndromes (MDS)
Acronym VCAM study
Scientific Title A clinical study to inspect whether live attenuated VZV vaccine inoculation induces antitumor immunity in patients with CML and patients with MDS
Scientific Title:Acronym VCAM study
Region
Japan

Condition
Condition Chronic myelogenous leukemia (CML) and myelodysplastic syndromes (MDS)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We inspect whether live attenuated VZV vaccine inoculation induces tumor specific cytotoxic T-lymphocyte (CTL) in patients with chronic myelogenous leukemia (CML) undergoing tyrosine kinase inhibitors (TKI) therapy and patients with myelodysplastic syndromes (MDS) undergoing Azacitidine (Aza), 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 vaccination can induce tumor specific CTL or not:
Evaluation of tumor specific CTLs before VZV vaccination and every 2 or 3 months for 12 months after the final inoculation
Key secondary outcomes 1) Enhancement of VZV specific cell mediated immunity (CMI) by VZV vaccination:
Evaluation of VZV specific CD4 and CD8 T-cells before VZV vaccination and every 2 or 3 months for 12 months after the final inoculation
2) The safety assessment of adverse events induced by VZV vaccination

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
Vaccine
Interventions/Control_1 VZV vaccine
Dissolve this product in 0.7 mL of the attached solvent (Japanese Pharmacopoeia for Injection Water), and inject 0.5 mL of this solution subcutaneously.

VZV immunization was conducted twice with at least 12 weeks interval between 2 courses using the live attenuated varicella virus (Oka /BIKEN) vaccine. Each course included up to 5 doses of vaccine with 1 to 4 weeks intervals.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are eligible as subjects of this study.
1) Chronic phase CML patients undergoing TKI therapy and MDS patients undergoing Aza therapy.
2) An anti-VZV antibody is positive [IAHA or EIA (IgG) is more than 4 times].
3) It is confirmed before VZV vaccine inoculation that cellar immunocompetence of patients is enough (with positive reactions of lymphocyte stimulation test for PHA and Con-A).
4) The patients have HLA type A*02:01(02:06) or A*24:02.
5) In the case that the patient is healing from cancer, which is not CML or MDS, developed more than 5 years ago. In the case that the patient has inactive cancer, which is not CML or MDS, developed in 5 years.
6) Women agree with contraception 1 month before and 2 months after VZV vaccination.
7) 20 years old or more and less than 80 years old.
8) In case of MDS, ineligible for hematopoietic stem cell transplantation, or the patient does not wish to receive it.
Key exclusion criteria Patients who meet any of the following criteria will be excluded from this study.
1) In the case of an infectious disease due to a virus belonging to Herpesviridae or a VZV vaccination other than the study vaccine in a year before inoculation of VZV vaccine.
2) Patients who have risk of allergy due to an ingredient of the product (Erythromycin lactobionate, Kanamycin sulfate).
3) HIV antibody is positive.
4) Women during pregnancy or lactating.
5) In case of the patient is complicated with psychosis or psychiatric symptoms, and it is judged that the enrollment of the study is difficult.
6) In the case that the patient has a disease, which is not CML or MDS, with the immunodeficiency or the immunosuppression. In the case that the patient receives an immunosuppressive therapy.
7) Any other reason that disqualifies the patients from participating in this study in the investigator's opinion.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Tatsuro
Middle name
Last name Jo
Organization Japanese Red Cross Society Nagasaki Genbaku Hospital
Division name Hematology
Zip code 852-8511
Address 3-15 Mori-machi, Nagasaki City, Nagasaki
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 Society Nagasaki Genbaku Hospital
Division name Hematology
Zip code 852-8511
Address 3-15 Mori-machi, Nagasaki City, Nagasaki
TEL 095-847-1511
Homepage URL
Email firetj@nagasaki-med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Society Nagasaki Genbaku Hospital
Institute
Department

Funding Source
Organization The Research Foundation for Microbial Diseases of Osaka University
Organization
Division
Category of Funding Organization Profit organization
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 jRCTs051180106
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本赤十字社長崎原爆病院(長崎県)
Japanese Red Cross Society Nagasaki Genbaku Hospital (Nagasaki)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 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
2018 Year 02 Month 26 Day
Date of IRB
2018 Year 03 Month 08 Day
Anticipated trial start date
2018 Year 04 Month 25 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Target sample size: 25 cases
Breakdown
CML: 10 cases, MDS RCMD:3-5 cases, MDS RAEB-1:3-5 cases, MDS RAEB-2:3-5 cases

Management information
Registered date
2018 Year 06 Month 14 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037618

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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