The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
1. Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001. 2. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.
National Cancer Center
Tokyo, Japan
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse).
Time frame: Treatment period (from the first IMP administration until the time of discontinuation)
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