Efficacy and Safety of Personalized Active Immunotherapy Using Autologous Peptides in Maintenance Therapy for Acute Myeloid Leukemia

What this Trial Is About

Acute myeloid leukemia (AML) is a common adult leukemia with high recurrence rates after standard chemotherapy, and less than 40% long-term survival. This trial focuses on a new personalized immunotherapy approach using vaccines made from a patient's own AML cells to prevent relapse. The study compares this vaccine given during versus after consolidation chemotherapy, aiming to find the best timing and establish safe, effective maintenance therapy for AML patients. Participants receive one of three treatments: routine consolidation chemotherapy alone, immunotherapy combined with consolidation chemotherapy, or immunotherapy after completing consolidation chemotherapy. The personalized vaccine is prepared using a patented method to cover all tumor antigens and delivered by intradermal injection. The study uses a randomized controlled design to evaluate these approaches. During the study, participants undergo regular assessments including overall survival and remission rates at various time points up to one year. Researchers monitor immune responses, disease progression, and safety. The trial lasts through consolidation and maintenance phases, with follow-up to evaluate long-term outcomes and treatment effects on AML recurrence and survival.

Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy