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Open, not recruiting

PEPN1812: Flotetuzumab Chemotherapy in Children with Relapsed or Refractory Acute Myeloid Leukemia

About this study

This study looks at how well the experimental drug flotetuzumab works when given to children and young adults with relapsed or refractory acute myeloid leukemia. Flotetuzumab is experimental because it has not been proven to work in young patients with this type of AML. Although flotetuzumab has been tested in adults, it has not been approved for use by the FDA for adults or for children.

We are using flotetuzumab because it seems to work against cancer in test tubes and animals. This is called a Phase I study because the goal is to find the highest dose of flotetuzumab that we can give safely. If there is no improvement in your leukemia after 2 cycles of treatment, your treatment with flotetuzumab will be stopped.

Eligibility overview

  • Younger than 21 years of age
  • Diagnosed with recurrent or refractory acute myeloid leukemia (AML)
  • Weigh more than 17kg
  • Fully recovered from the acute toxic effects of all prior anti-cancer therapy

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

Phase I Trial of Flotetuzumab, a CD123 X CD3 Dual Affinity Re-Targeting (DART) Molecule, in Pediatric Patients with Relapsed/Refractory AML

Study goal:

The main goal of this study is to find the highest dose of flotetuzumab that we can give safely to children and young adults.


Acute Myeloid Leukemia (AML)


Younger than 21 years of age

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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