Children's Hospital of Philadelphia(115.3 mi away)Contact
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This phase I trial studies the side effects and best dose of flotetuzumab and how well it
works in treating patients with acute myeloid leukemia that has come back (recurrent) or has
not responded to treatment (refractory). Immunotherapy with flotetuzumab may induce changes
in body's immune system and may interfere with the ability of leukemia cells to grow and
spread. Giving flotetuzumab may stop the leukemia from growing or shrink for a period of
time, as well as possibly lessening symptoms, such as pain, that are caused by the leukemia.
I. To assess the safety and tolerability of flotetuzumab administered by continuous
intravenous (IV) infusion to pediatric patients < 21 years of age with relapsed or refractory
acute myeloid leukemia (AML).
II. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of
flotetuzumab administered by continuous IV infusion to pediatric patients < 21 years of age
with relapsed or refractory AML.
I. To characterize the pharmacokinetics of flotetuzumab in pediatric patients with relapsed
or refractory AML.
II. To define preliminarily the anti-tumor activity of flotetuzumab within the confines of a
phase 1 study and correlate potential activity with baseline disease burden at study entry.
III. To monitor anti-drug antibody (ADA) production and characterize the immunogenicity of
I. To evaluate changes in T-lymphocyte population numbers before and after flotetuzumab
II. To evaluate the tumor microenvironment and cytokine production by immune effector cells
before and after flotetuzumab treatment.
III. To quantify CD123 surface expression on AML cells at baseline and evaluate expression as
a potential biomarker of flotetuzumab response.
OUTLINE: This is a dose-escalation study of flotetuzumab.
Patients receive cytarabine intrathecally (IT) on days -6 to 0 prior to cycle 1. Patients may
receive additional doses of cytarabine on day 1 of subsequent cycles per physician
discretion. Patients also receive flotetuzumab IV continuously for 28 days. Treatment repeats
every 29 days for up to 6 cycles in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up at 30 days.
Clinical Study Identifier
Children's Oncology Group
Last Modified on
2 December 2020
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