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Completed

NCT Number: NCT01475370

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

OCV-501

Drug
  • 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 outcomes

  1. Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria

    Time frame: Treatment period (from the first IMP administration until the time of discontinuation)

    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).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2011
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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