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

NCT ID: NCT01440920

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

0.3 mg

Group Type: EXPERIMENTAL

OCV-501

Intervention Type: DRUG

subcutaneously administered once a week, 4 times at the dose of 0.3 mg

Cohort 2

1 mg

Group Type: EXPERIMENTAL

OCV-501

Intervention Type: DRUG

subcutaneously administered once a week, 4 times at the dose of 1 mg

Cohort 3

3 mg

Group Type: EXPERIMENTAL

OCV-501

Intervention Type: DRUG

subcutaneously administered once a week, 4 times at the dose of 3 mg

Interventions

OCV-501

subcutaneously administered once a week, 4 times at the dose of 0.3 mg

Intervention Type: DRUG

OCV-501

subcutaneously administered once a week, 4 times at the dose of 1 mg

Intervention Type: DRUG

OCV-501

subcutaneously administered once a week, 4 times at the dose of 3 mg

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center

Tokyo, , Japan

Countries

Japan

Other Identifiers

JapicCTI-111623

Identifier Type: OTHER

Identifier Source: secondary_id

311-10-001

Identifier Type: -

Identifier Source: org_study_id