NCT01961882

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4.1 years

First QC Date

October 10, 2013

Results QC Date

February 11, 2021

Last Update Submit

March 2, 2021

Conditions

Acute Myeloid Leukemia

Keywords

OCV-501Acute Myeloid LeukemiaAntigen specific cancer immunotherapeutic

Outcome Measures

Primary Outcomes (1)

  • Disease-Free Survival

    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.

    2 years (treatment period)

Secondary Outcomes (1)

  • Overall Survival

    2 years (treatment period)

Study Arms (2)

OCV-501 arm

EXPERIMENTAL
Drug: OCV-501

Placebo arm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OCV-501DRUG
OCV-501 arm
PlaceboDRUG
Placebo arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Kaoshiung, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Jun-ichi Hashimoto, PhD

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

March 26, 2021

Results First Posted

March 26, 2021

Record last verified: 2021-03

Locations

JP(8)KR(2)TW(4)