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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01440920
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: OCV-501 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
Study Start Date : September 2011
Primary Completion Date : March 2013
Study Completion Date : July 2013

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440920

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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01440920     History of Changes
Other Study ID Numbers: 311-10-001
JapicCTI-111623 ( Other Identifier: JAPIC )
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type