Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
February 10, 2021 updated by: Otsuka Pharmaceutical Co., Ltd.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tokyo, Japan
- National Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: OCV-501
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
Time Frame: 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).
|
Treatment period (from the first IMP administration until the time of discontinuation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2012
Primary Completion (Actual)
December 22, 2016
Study Completion (Actual)
December 22, 2016
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 311-10-002
- JapicCTI-111646 (Other Identifier: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.