myeloproliferative neoplasms (Polycythemia vera, Essential thrombocythemia,Essential thrombocytosis) MPN (PV, ET)
Conditions
Interventions
Montanide ISA-51- adjuvanted, three WT1-derived peptides (WT1-126, mWT1-235, WT1-332) are intradermally administered eight times at three-week intervals. Peptide dose was 0.5 mg each for first and sec
Sponsors
Osaka university Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A disease-notified patient with PV or ET according to WHO classification (2016) - Abnormally high WT1 mRNA level has been recorded >= 100 copies and 2,000 copies /microgram RNA for PBMC and bone marrow samples, respectively. - HLA-A 24:02 or 02:01 - 16-85 years old. - PS: 0-2 - Neu >=1,000/ul, Plt>= 50,000/ul - serum ALT <=120 U/L - serum total Bil <= 2.0 mg/dL - serum Alb >=2.5 g/dL - serum Creatinine <= 2.0 mg/dL - ECG: no severe abnormal findings - SpO2 >= 94 percent - written informed consent obtained
Exclusion criteria
Exclusion criteria: - >=10% of blasts in the peripheral blood - active infectious disease including tuberculosis. - active autoimmune disease and/or collagen disease -severe complications (grade >=3 according to CTCAE v4.0) - severe mental disorders - participation in other clinical trial which could affect the results of the study - having other malignant disease within three years prior to the registration -Dicided as inadequate by the principal investigator or a subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction of WT1-specific immune responses Clinical efficacy | — |
Countries
Japan
Contacts
Public ContactYusuke OJI
Osaka university Dept. Cancer vaccine immunotherapy
Outcome results
None listed