Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment ocv-501
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ocv-501
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. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.

Primary Outcomes

Measure
Occurrence of severe toxicities as defined in the protocol
time frame:

Secondary Outcomes

Measure
Recurrence based on the Response Evaluation Criteria by the International Working Group
time frame:

Eligibility Criteria

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).

Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..