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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221583

Enrollment

Registered

2011-09-14

Start date

2011-10-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

investigational material(s) Generic name etc : OCV-501 Cohort 1 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key Inclusion criteria 1) Acute myeloid leukemia (AML) patients including patients with secondary leukemia. However, acute promyelocytic leukemia (APL) patients who were apparently advanced from myelodysplastic syndrome (MDS) and AML patients accompanied by t(15;17)(q22;q12),(PML/RARalpha) should be excluded. 2) Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy. 3) Age: equal or more than 60years of age(at the time of signature of the informed consent form) 4) Sex: Male and Female 5) Patients who are capable of giving informed consent 6) Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR. 7) 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.

Exclusion criteria

Exclusion criteria: Key exclusion criteria 1) Patients who are scheduled for a bone marrow transplantation 2) Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids. 3) Patients with uncontrollable active infectious diseases 4) Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases 5) Immunocompetent patients 6) Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia

Design outcomes

Primary

Measure	Time frame
safety Dose limiting toxicity	—

Secondary

Measure	Time frame
safety Adverse events, Clinical laboratory tests, ECOG PS, Vital signs (blood pressure, pulse rate, body temperature), Body weight, 12-Lead ECG, Pulse oximetry, Chest X-ray, Observation of administered site efficacy Recurrence based on the Response Evaluation Criteria by the International Working Group	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026