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Completed

NCT Number: NCT01961882

A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.

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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 2

Primary location

Chubu Region, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
  • Patients who are 60 years or older.
  • Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.

Exclusion criteria

  • Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
  • Patients who are scheduled for hematopoietic stem cell transplantation.
  • Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
  • Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
  • Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.
  • Patients who have cirrhosis.
  • Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.

Treatment and study plan

OCV-501

Drug

Placebo

Drug

Primary outcomes

  1. Disease-Free Survival

    Time frame: 2 years (treatment period)

    Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years (treatment period)

    Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2013
Registry last updated
Mar 26, 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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