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

Phase 1
60 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity

Outcome Time Frame:

4 Weeks

Safety Issue:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2011

Completion Date:

July 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • WT1
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid