Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
This trial is active, not recruiting.
|Condition||acute myeloid leukemia|
|Sponsor||Otsuka Pharmaceutical Co., Ltd.|
|Start date||November 2011|
|End date||December 2018|
|Trial size||18 participants|
|Trial identifier||NCT01475370, 311-10-002, JapicCTI-111646|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Occurrence of severe toxicities as defined in the protocol
Recurrence based on the Response Evaluation Criteria by the International Working Group
Male or female participants at least 60 years old.
- 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
- 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).
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