Flotetuzumab for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen by Adam J Lamble

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adam J Lamble

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Eligibility Criteria

This trial is for children with acute myeloid leukemia (AML) that has returned or hasn't responded to treatment. They must weigh at least 17 kg, have recovered from previous treatments' side effects, and not been treated with flotetuzumab before. Patients should have a certain level of organ function and blood counts, no history of certain genetic syndromes (except Down syndrome), and not be on specific medications that could interfere with the study.

Inclusion Criteria

My condition did not improve after 2 or more chemotherapy cycles.

I weigh at least 17 kilograms.

Shortening fraction of >/= 27% by echocardiogram, or ejection fraction of >/= 50% by gated radionuclide study

Exclusion Criteria

I am not on any cancer treatments, except possibly hydroxyurea.

I do not have any infections that are currently uncontrolled.

Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study

Treatment Details

Interventions

• Flotetuzumab (Bispecific Antibody)

Trial Overview The trial is testing the safety and optimal dose of flotetuzumab in pediatric patients. Flotetuzumab is an immunotherapy drug designed to target AML cells. The study will also observe how well it works against recurrent or refractory AML in children, as well as its impact on the immune system.

Participant Groups

Group I: Treatment (cytarabine, flotetuzumab) Experimental Treatment 2 Interventions

Patients receive cytarabine 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 toxicity.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School