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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: OCV-501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440920

311-10-001

JapicCTI-111623 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Cohort 1

Experimental group

Description:

0.3 mg

Treatment:

Drug: OCV-501

Drug: OCV-501

Drug: OCV-501

Cohort 2

Experimental group

Description:

1 mg

Treatment:

Drug: OCV-501

Drug: OCV-501

Drug: OCV-501

Cohort 3

Experimental group

Description:

3 mg

Treatment:

Drug: OCV-501

Drug: OCV-501

Drug: OCV-501