A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222379

Enrollment

120

Registered

2014-01-29

Start date

2013-10-24

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

Elderly Patients With Acute Myeloid Leukemia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (one or more courses) - Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee (and other criteria)

Exclusion criteria

Exclusion criteria: - Patients who have acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (PML/RARA) karyotype abnormalities, and other variant types. - Patients who are scheduled for hematopoietic stem cell transplantation - Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial - Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial - Patients who are HIV antibody positive or HBV-DNA positive, or have unrecovered chronic hepatitis C with positive HCV antibody - Patients who have cirrhosis - Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons (and other criteria)

Design outcomes

Primary

Measure	Time frame
efficacy Disease-Free Survival	—

Secondary

Measure	Time frame
efficacy Overall Survival safety Safety	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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