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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01440920
First received: September 15, 2011
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence based on the Response Evaluation Criteria by the International Working Group [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440920

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

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01440920     History of Changes
Other Study ID Numbers: 311-10-001, JapicCTI-111623
Study First Received: September 15, 2011
Last Updated: November 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Acute myeloid leukemia
WT1

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

ClinicalTrials.gov processed this record on October 16, 2014