ovel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study.
- Conditions
- Adult T-cell leukemia/lymphoma
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 9
Not provided
1) Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases, sever allergy and severe infectious disease. 2) Patients who should receive systemic administration of steroid or immunosuppressive agents. 3) Non-hematological adverse event Grade 3 or more due to KW-0761 before the trial are not recover 4) After allogeneic hematopoietic stem cell transplantation, or allograft is planned 5) Presence of active central nerve lesion 6) Pregnant, lactating, or possibly pregnant women, or willing to be pregnant Severe psychiatric disorder 7) Complication with psychosis or psychotic symptoms 8) History of HAM/TSP 9) Active multiple cancers 10) Inappropriate for study entry judged by an attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of Tax-targeting DC vaccine combined with anti-CCR4 antibody
- Secondary Outcome Measures
Name Time Method 1) anti-ATL effect 2) progression- free survival 3) time to new treatment (TTNT) 4) tumor marker (sIL-2R) 5) HTLV-1 proviral load 6) CD4+CD25+Foxp3+ cells 7) level of Mogamulizumab 8) anti-ATL effect and adverse event in the follow up period