Adult T-cell leukemia/lymphoma
Conditions
Interventions
VZV vaccine
Combination chemotherapy including Mogamulizumab
Sponsors
Japanese Red Cross Nagasaki Genbaku Hospital
The Research Foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether VZV vaccine inoculation can induce anti-HTLV-I specific CTL or not? | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety assessment of adverse events, such as herpes zoster, induced by VZV vaccine inoculation. | — |
Countries
Japan
Contacts
Public ContactTatsuro Jo
Japanese Red Cross Nagasaki Genbaku Hospital Hematology
Outcome results
None listed