drugset / Trial / NCT04168502

Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

NCT04168502

Phase 3 Recruiting 414 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.

Timeline

Start
2020-09-24
Primary completion
2025-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2