Status:
COMPLETED
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
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 sta...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01440920
Start Date
September 1 2011
End Date
July 1 2013
Last Update
March 8 2021
Active Locations (1)
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1
National Cancer Center
Tokyo, Japan