drugset / Trial / NCT04158739

Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia

NCT04158739

Phase 1 Active not recruiting 16 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory). This study also determines the safest dose of flotetuzumab to use in children with AML. As an immunotherapy, flotetuzumab may also cause changes in the body's normal immune system, which are also under study in this trial.

Timeline

Start
2020-01-22
Primary completion
2022-09-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Flotetuzumab Monoclonal antibody Intravenous
Background Cytarabine Small molecule Other