Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
2 other identifiers
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedStudy Start
First participant enrolled
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedResults Posted
Study results publicly available
March 2, 2021
CompletedMarch 2, 2021
February 1, 2021
4.9 years
October 18, 2011
February 10, 2021
February 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
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)
Study Arms (1)
OCV-501
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Otsuka Pharmaceutical Co., LTD.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
November 21, 2011
Study Start
January 24, 2012
Primary Completion
December 22, 2016
Study Completion
December 22, 2016
Last Updated
March 2, 2021
Results First Posted
March 2, 2021
Record last verified: 2021-02