Clinical trialNCT04158739Active, not recruitingPhase 1Interventional

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

SponsorChildren's Oncology GroupEnrollment16Recurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Adam J Lamble
Pediatric Early Phase Clinical Trial Network
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Children'S Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Lurie Children'S Hospital-Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
C S Mott Children'S Hospital
Ann Arbor, Michigan, United States
University of Minnesota/masonic Cancer Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center
New York, New York, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Saint Jude Children'S Research Hospital
Memphis, Tennessee, United States
Baylor College of Medicine/dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cytarabine →Flotetuzumab

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Jan 2020
Primary completion: 30 Sept 2022
Completion: 31 Dec 2026
Last update posted: 9 Jun 2026
Registered enrollment: 16
Registry id: NCT04158739

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.