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

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ClinicalTrials.gov Identifier: NCT01475370
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: OCV-501 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 24, 2012
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 22, 2016


Arm Intervention/treatment
Experimental: OCV-501 Drug: 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.



Primary Outcome Measures :
  1. Occurrence of severe toxicities as defined in the protocol

Secondary Outcome Measures :
  1. Recurrence based on the Response Evaluation Criteria by the International Working Group


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475370


Locations
Japan
National Cancer Center
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01475370     History of Changes
Other Study ID Numbers: 311-10-002
JapicCTI-111646 ( Other Identifier: JAPIC )
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Acute myeloid leukemia
WT1

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms