NCT01440920

Brief Summary

The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

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

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

March 8, 2021

Completed
Last Updated

March 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

September 15, 2011

Results QC Date

February 15, 2021

Last Update Submit

February 15, 2021

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaWT1

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Dose Limiting Toxicities

    Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product \[IMP\] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests. * Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy * Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT.

    4 Weeks

Secondary Outcomes (1)

  • Recurrence Based on the Response Evaluation Criteria by the International Working Group

    4 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

0.3 mg

Drug: OCV-501

Cohort 2

EXPERIMENTAL

1 mg

Drug: OCV-501

Cohort 3

EXPERIMENTAL

3 mg

Drug: OCV-501

Interventions

OCV-501DRUG

subcutaneously administered once a week, 4 times at the dose of 0.3 mg

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.
  • Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy.
  • Age: ≥ 60years of age(at the time of signature of the informed consent form)
  • Sex: Male and Female
  • Patients who are capable of giving informed consent
  • Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.
  • Patients must be one of the following HLA DRB1 types: HLA-DRB1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01.

You may not qualify if:

  • Patients who are scheduled for a bone marrow transplantation
  • Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids.
  • Patients with uncontrollable active infectious diseases
  • Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases
  • Immunocompetent patients
  • Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Tokyo, Japan

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 27, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

March 8, 2021

Results First Posted

March 8, 2021

Record last verified: 2021-02

Locations

JP(1)