Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, Myelodysplastic syndrome with high risk of relapse and/or excess blasts
Conditions
Interventions
Sponsors
National Cancer Research Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, or Myelodysplastic syndrome with high risk of relapse (IPSS >=int-2 or WPSS >=high) or excess blasts (RAEB (FAB), RAEB-t (FAB), RAEB-1 (WHO2008), or RAEB-2 (WHO2008)). 2. Patients in hematological complete remission after allogeneic hematopoietic stem cell transplantation. 3. Patients with any one of HLA-A0201, HLA-A0206 or HLA-A2402 genotype. 4. Patients with confirmation of WT1 expression in the peripheral blood (>50copy/ugRNA) or bone marrow (>1500copy/ugRNA) by real-time PCR assay at any time after the diagnosis of leukemia. 5. More than 28 days from reducing immunosuppressive drugs to 3mg/kg of cyclosporin or 0.1mg/kg of tacrolimus and 10 mg/body of prednisolone or less. 6. Patients with ECOG performance status of 0 to 2 7. Patients aged 20 years old and above with no upper limit. 8. Patients with well preserved main organ function. (bone marrow, heart, lung, liver, kidney etc.) Neutrophils above 1,000 Platelets above 50,000 GOT less than 5-times the upper limit of normal GPT less than 5-times the upper limit of normal Bilirubin less than 3-times the upper limit of normal Serum creatinine less than 3-times the upper limit of normal Saturation above 95% at room air No electrocardiogram abnormalities which requires treatment. 9. Patients who are expected to survive for at least 3 months. 10. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: Patients with any one of the criteria are ineligible. 1. Patients with active acute GVHD or extended chronic GVHD (including bronchiolitis obliterans or bronchiolitis obliterans organizing pneumonia). 2. Patients receiving over permitted dose of immunosuppressive drugs or corticosteroids . 3. Patients with active infection including positive cytomegalovirus antigenemia which requires treatment. 4. Patients with positive HBs antigen, or HCV antibody. Patients with active hepatitis or cirrhosis. 5. Pregnant or breast feeding patients. Patients who have a possibility of pregnancy or desire for baby. 6. Patients with active autoimmune disease (including hypothyroidism, idiopathic thrombocytopenic purpura, autoimmune hepatitis) or with a history of those diseases. 7. Patients with active interstitial pneumonia or its history. 8. Patients with a history of allergy or severe adverse reaction against biological agents. 9. Patients with a severe psychological disorder and considered unable to obtain informed consent for the study. 10. Patients with uncontrollable central nervous invasion. 11. Patients participating in other clinical trials*. * If the safety and anti-tumor effect of vaccine therapy is obviously not considered to be affected by the other clinical trials, the patient doesn't need to be excluded. 12. Patients who are considered ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and the immunological optimal dose of WT1 vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Over all survival, Progression free survival | — |
Countries
Japan
Outcome results
None listed