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

This study is currently recruiting participants.
Verified April 2012 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01475370
First received: October 18, 2011
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Drug: OCV-501
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Occurrence of severe toxicities as defined in the protocol [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence based on the Response Evaluation Criteria by the International Working Group [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475370

Contacts
Contact: Jun Yoshida Chiken_CT@ml.res.ncc.go.jp

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

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01475370     History of Changes
Other Study ID Numbers: 311-10-002, JapicCTI-111646
Study First Received: October 18, 2011
Last Updated: April 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 22, 2013