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A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

This study has been completed.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd. Identifier:
First received: September 15, 2011
Last updated: November 10, 2013
Last verified: November 2013
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.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: OCV-501
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: 4 Weeks ]

Secondary Outcome Measures:
  • Recurrence based on the Response Evaluation Criteria by the International Working Group [ Time Frame: 4 weeks ]

Enrollment: 9
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
0.3 mg
Drug: OCV-501
subcutaneously administered once a week, 4 times at the dose of 0.3 mg
Experimental: Cohort 2
1 mg
Drug: OCV-501
subcutaneously administered once a week, 4 times at the dose of 1 mg
Experimental: Cohort 3
3 mg
Drug: OCV-501
subcutaneously administered once a week, 4 times at the dose of 3 mg


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01440920

National Cancer Center
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01440920     History of Changes
Other Study ID Numbers: 311-10-001
JapicCTI-111623 ( Other Identifier: JAPIC )
Study First Received: September 15, 2011
Last Updated: November 10, 2013

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on May 25, 2017