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

Acute Myeloid Leukemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475370
• Other study ID #: 311-10-002
• Secondary ID: JapicCTI-111646
• Status: Completed
• Phase: Phase 1
• Start date: January 24, 2012
• Est. completion date: December 22, 2016

Study information

• Verified date: February 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 22, 2016
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	National Cancer Center	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)