High-risk MDS and MDS overt AML
Conditions
Interventions
3.0mg of WT1 peptide and adjuvant agent well be administrated intradermally. The administration interval is essentially every week.
Sponsors
Department of Hematology and respiratory Medicine, School of Medicine, Kochi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients diagnosed as MDS by the WHO criteria. Among them the high-risk and very high risk groups by the WHO prognosis scoring system are recruited. 2) patients who have been informed of the disease 3) patients who have no option to standard therapies or those who chose this trial over the standard therapy. Patients are not eligible to this trial if treated with the previous therapy within 4 weeks. 4) patients bearing at least one of HLA-A*24:02, A*02:01, A*02:06, A*02:07 genes. 5) Overexpression of WT1 gene was observed by real-time PCR at least once in the bone marrow or peripheral blood. normal threshold of the WT1 transcripts: in bone marrow or peripheral blood: =< 250 copy/ug RNA Alternatively, over-expression of WT1 protein is confirmed by flow cytometry. 6) The presence of residual tumors in the bone marrow or peripheral blood are confirmed by one of the clinical tests listed below. The presence of leukemic blasts Overexpression of the WT1 transcript The presence of canonical chromosomal abnormalities have been confirmed by chromosome examination, FISH or analysis of chimeric transcripts. 7) At least 8 days have passed after the administration of either hematopoietic factors, transfusion of platelets or RBC. blasts in the bone marrow and peripheral blood < 50%, neutrophil >= 500 /ul platelet >= 20,000 /ul Hb >= 6.5 g/dl 8) No involvement of the central nervous system or under control 9) 20 years of age or older, and less than 85 years 10) The performance status should be between 0-1 by the ECOG criteria 11) Functions of the major organs are preserved. 12) No serious complications, No double tumors including hematopoietic malignancy. 13) Written consent have been obtained from patients.
Exclusion criteria
Exclusion criteria: 1)patients with infectious diseases including active Tuberculosis which are poorly controlled. 2)patients with serious comorbidities (generally those with grade 3 or higher by the NCI-CTC criteria ver 3.0) 3)pregnant women, Breast feeding mothers 4)patients with severe mental problems. 5)patients who have already been recruited in other clinical trials. 6) Patients who have dropped out after starting this clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : adverse events of grade 3 or higher, all adverse events by the CTCAE criteria Phase II : progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate, survival rate, overall survival, maximal response, specific immune responses | — |
Countries
Japan
Contacts
Public ContactKeiko Udaka
School of Medicine, Kochi University Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Outcome results
None listed