Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
- Registration Number
- NCT01475370
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
- Patients who are capable of giving informed consent
Exclusion Criteria
- Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria.
- Patients who have participated in any other clinical trials , excluding the Study 311-10-001).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCV-501 OCV-501 -
- Primary Outcome Measures
Name Time Method Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria Treatment period (from the first IMP administration until the time of discontinuation) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Cancer Center
🇯🇵Tokyo, Japan