A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
- Patients with acute myeloid leukemia including patients with secondary leukemia.
However, the patients with MDS apparently evolved itno AML and patients with AML
accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.
- Patients who achieved the first complete remission after the induction regimen and
finished a standard consolidation therapy.
- Age: ≥ 60years of age(at the time of signature of the informed consent form)
- Sex: Male and Female
- Patients who are capable of giving informed consent
- Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.
- Patients must be one of the following HLA DRB1 types: HLA-DRB1*01:01, *04:05, *15:01,
*15:02, *08:03 and *09:01.
Key Exclusion Criteria:
- Patients who are scheduled for a bone marrow transplantation
- Patients who were administered exceeded acceptable therapeutic dose of
immunosuppressants and adrenal cortical steroids.
- Patients with uncontrollable active infectious diseases
- Patients with autoimmune diseases (including Hashimoto's disease, idiopathic
thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of
active autoimmune diseases
- Immunocompetent patients
- Patients with a complication of interstitial pneumonia or with a medical history of