A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia/lymphoma

JRCT ID: jRCTs051180107

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia/lymphoma
• Date of first enrollment: 31/05/2016
• Target sample size: 10
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Whether VZV vaccination can induce anti-HTLV-1 specific CTL or not.
• Secondary Outcome: The safety assessment of adverse events induced by VZV vaccination

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible as subjects of this study.
1) HTLV-1 antibody is positive. The diagnosis is made as a peripheral lymphoid tumor cytologically or histopathologically
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 csllular 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
8) Ineligible for hematopoietic stem cell transplantation, or the patient does not wish to receive it

Exclude 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) 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 or lactating
6) In case of 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

Related Information

• Primary Sponsor: Jo Tatsuro

Source(s) of Monetary Support

The Research Foundation for Microbial Diseases of Osaka University
(supported from Apr 28, 2016 to Dec 31, 2019)

• Secondary ID(s): UMIN000021750