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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Drug: OCV-501; Drug: OCV-501; Drug: OCV-501

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 0.3 mg	Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 0.3 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 1 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 3 mg
Experimental: Cohort 2; 1 mg	Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 0.3 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 1 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 3 mg
Experimental: Cohort 3; 3 mg	Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 0.3 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 1 mg; Drug: OCV-501; subcutaneously administered once a week, 4 times at the dose of 3 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Dose Limiting Toxicities	Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product [IMP] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests.; Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy; Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT.	4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Based on the Response Evaluation Criteria by the International Working Group	A case will be designated as relapse if any of the following occur. Reappearance of leukemic blast cells in the peripheral blood or ≥5% blast cells in the bone marrow after complete remission (morphologic relapse).	4 weeks

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia; WT1
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 311-10-001; JapicCTI-111623 (Other Identifier: JAPIC)