Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-24

Study Completion Date

2016-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCV-501

Group Type EXPERIMENTAL

OCV-501

Intervention Type DRUG

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.

Interventions

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OCV-501

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.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No