Adult T cell Leukemia/Lymphoma
Conditions
Interventions
Simultaneous administration of NY-ESO-1+PolyICLC and mogamulizumab
Sequential administration of NY-ESO-1+PolyICLC after mogamulizumab
mogamulizumab without vaccination
Sponsors
Osaka University Graduate School of Medicine
Immunology Frontier Research Center, Osaka University National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Relapsed or refractory ATLL patients with ATLA antibody. 2. <=80 and 20>= years of age. 3. Indication for treatment with mogamulizumabb. 4. No history of treatment with immunotherapy with NY-ESO-1 , or mogamulizumab within 4 months before enrollment. 5. ATLL with expression of NY-ESO-1. 6. ECOG performance status of 0 to 2. 7. Women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation. 8. Sign an Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Severe underlying diseases. 2. The patient has at least one clinical laboratory value as follows: 1) Absolute neutrophil count <1.500/mm3 2) Hemoglobin <8.0g/dL (blood transfusion is acceptable) 3) Platelet count < 50,000/mm3 4) Serum total bilirubin>1.5*ULN (except for patient with Gilberts syndrome for whom the limit is 2*ULN) 5) AST> 2*ULN (upper limit of normal) and ALT> 2*ULN 6) Serum creatinine > 1.5*ULN 7) Corrected Serum calcium > 11mg/dL 8) Percutaneous arterial oxygen saturation by pulse oximetry (SpO2) < 90% 3. Positive for HCV antibody, HIV. 4. Positive for HBs antigen or HBs antibody or HBc antibody, and HBV-DNA is over the limit of quantification. 5. Other malignancies within 5 years. 6. Needs treatment with corticosteroids, or any other immunosuppressive agents. 7. Any autoimmune disease. 8. Any history of severe hypersensitivity. 9. Any active infectious complication. 10. Uncontrolled bleeding disorder. 11. Pregnant or lactating. 12. Investigator considers to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1a To evaluate the safety of NY-ESO-1 vaccination with mogamulizumab. 1b 1.To evaluate the induction of NY-ESO-1 specific immune responses by vaccination with or after mogamulizumab. 2.To evaluate the safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1a To observe the induction of NY-ESO-1 specific immune responses. 1b 1 To evaluate the tumor responses by NY-ESO-1 vaccination with or after mogamulizumab. 2 To evaluate additional immune responses. | — |
Countries
Japan
Contacts
Public ContactSachiko Ezoe
Osaka University Hospital Department of Medecal innovation
Outcome results
None listed