Back to resultsStudy of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OCV-501
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, WT1
Eligibility Criteria
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).
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCV-501
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01475370
First Posted
October 18, 2011
Last Updated
February 10, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01475370
Brief Title
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2012 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia, WT1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCV-501
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OCV-501
Intervention Description
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 Outcome Measure Information:
Title
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
Description
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).
Time Frame
Treatment period (from the first IMP administration until the time of discontinuation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
National Cancer Center
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
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