Efficacy and safety of Wilms' tumor 1 helper peptide OCV-501 in elderly patients with acute myeloid leukemia: a multicenter, randomized, double-blind, placebo-controlled phase 2 trial.

ABSTRACT:

Purpose

Complete remission (CR) of acute myeloid leukemia (AML) in elderly patients has a short duration, and there is no suitable post-remission therapy. We explored the role of the Wilms' tumor 1 helper peptide OCV-501 to prevent recurrence after remission.

Methods

This placebo-controlled phase 2 study was designed to evaluate accurately the efficacy and immunogenicity of OCV-501 in elderly AML patients. Elderly AML patients who achieved first CR were randomly allocated to receive either OCV-501 (N = 69) or placebo (N = 65) once a week for eight weeks and then every two weeks until week 104. The primary endpoint was disease-free survival (DFS).

Results

Nineteen (27.5%) patients in the OCV-501 group and 23 (35.4%) patients in the placebo group completed the study wit

SUBMITTER: Kiguchi T 

PROVIDER: S-EPMC10992744 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature