A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antige

Phase 1

Recruiting

• Conditions: Adult T cell Leukemia/Lymphoma

• Registration Number: JPRN-UMIN000017748
• Lead Sponsor: Osaka University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-01
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1a To observe the induction of NY-ESO-1 specific immune responses. 1b 1To evaluate the tumor responses by NY-ESO-1 vaccination with or after mogamulizumab. 2To evaluate additional immune responses.