A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Key Inclusion Criteria:

• 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 interstitial pneumonia