Conventional therapy-resistant acute or chronic leukemia, elderly patients with hematological malignancies who are not eligible for standard chemotherapy and/or allogeneic or autologous hematopietic stem cell transplantation, relapsed acute or chronic leukemia and advanced phase of myelodysplastic syndrome after allogenic or autologous hematopietic stem cell transplantation, acute leukemia in 1st remission with high risk of relapse.
Conditions
Interventions
Cohort1 patients receive 0.5mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
Cohort2 patients receive 1.0mg of Aurora-A kinase peptide in combinat
Sponsors
Department of Bioregulatory
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Candidates should meet all following requirements. (1)Patients with leukemias, myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disease (MD/MPD) and myeloproliferative disease (MPD) diagnosed on the basis of WHO classification. (2)Patients who are given their diagnoses. (3)Patients who are not eligible for standard therapy, or who intend to take this therapy because they achieved the therapeutic insufficiency by standard therapy, or patients who desire this therapy but not standard therapy. Patients who have no clinical efficacy for longer than 4 weeks after previous therapy. (4) Positve for HLA-A*0201 or A*2402. (5)Leukemic cells in peripheral blood (PB) or bone marrow (BM) display augmented Aurora-A kinase mRNA 2.5 times more than that of PBMC, at least one time, by quantitative RT-PCR. (6)At the initiation of vaccination, residual disease in BM or PB is confirmed by at least one of following methods. (a)Persistent leukemic cells in periphery or BM. (b)Overexpression of Aurora-A kinase mRNA by qRT-PCR. (c) Residual leukemia is shown by leukemia-specific genetic markers including chromosomal analysis, FISH and chimeric genes. (7) Leukemic blast in BM is <50%, and <50% in PB with >or= 500/microlitter of neutrophile count, >or=20,000/microlitter of platelet count, and >or= 7.0 g/dl of Hemoglobin.Without administration of Granulocyte-colony stimulating factor within 7 days, platelet count and Hb can be controlled by transfusions. (8)Without or with well-controlled central nervous system lesion. (9) Aged between >or= 20 y.o and <80 y.o. (10) ECOG-scale Performance status 0-1. (11) Functions of vital organs are preserved. (12) Without other life-threatening diseases, and active overlapping cancers (including hematological malignancies). (13) Patients can give written informed consents.
Exclusion criteria
Exclusion criteria: (1) Patients with uncontrolled and active infectious disease including active tuberculosis. (2) Patients suffering from severe complications including malignant hypertension, severe congestive heart failure, severe coronary disease, recent myocardial infarction within 3 months, end-staged liver cirrhosis, uncontrolled diabetes mellitus, severe pulmonary fibrosis, and active interstitial pneumonia, and so on. (3) Patients who are pregnant or currently lactating. (4) Patients who suffering from severe psychiatric disease. (5) Patients who are already enrolled into other clinical trials. (6) Patients who are once enrolled but ended with some reasons (to inhibit the double enrollment.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event profile and anti-leukemia effect. | — |
Secondary
| Measure | Time frame |
|---|---|
| Generation of Aurora-A kinase-specific CD8+ T-cell in peripheral blood, progression free survival, relapse rate and progression free survival rate at 3 month and 6 months after the induction of Aurora-A kinase peptide vaccination. | — |
Countries
Japan
Contacts
Public ContactHiroshi Fujiwara
Ehime University Department of Bioregulatory
Outcome results
None listed