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

Phase 1

Completed

• Conditions: Acute myeloid leukemia

• Registration Number: JPRN-jRCT2080221583
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

o DLT was reported in any of the cohorts and the MTD was considered to be 3 mg or more. There was no evidence of major safety problems in any of the cohorts. OCV-501 was shown to be safe and well tolerated in AML patients in a dose range of 0.3 mg to 3 mg.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-14
• Study Completion: 2013-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 9

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
safety<br>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<br><br>efficacy<br>Recurrence based on the Response Evaluation Criteria by the International Working Group