Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia (NCT04158739)
A Phase 1 Trial of the CD123 X CD3 DART Molecule Flotetuzumab (NSC#808294) in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: Not specified to 20 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- Children's Hospital of Alabama — Birmingham, Alabama
- Children's Hospital Los Angeles — Los Angeles, California
- Children's Hospital of Orange County — Orange, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Children's National Medical Center — Washington D.C., District of Columbia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia
- Lurie Children's Hospital-Chicago — Chicago, Illinois
- Riley Hospital for Children — Indianapolis, Indiana
- C S Mott Children's Hospital — Ann Arbor, Michigan
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
- Saint Jude Children's Research Hospital — Memphis, Tennessee
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas
- Seattle Children's Hospital — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Recurrent Acute Myeloid Leukemia
- Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax — Duarte, California
- Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation — Birmingham, Alabama
- CPX-351 Plus Enasidenib for Relapsed AML — Los Angeles, California
- Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant — Houston, Texas
- Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia — Duarte, California
Explore by condition: All Recurrent Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.