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.
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).
Call for more information