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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: OCV-501
* Drug: OCV-501
* Drug: OCV-501


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WT1, Acute myeloid leukemia