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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01475370
First received: October 18, 2011
Last updated: November 10, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475370

Locations
Japan
National Cancer Center
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: November 10, 2013
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
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014