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Bispecific Antibody

Flotetuzumab for Acute Myelogenous Leukemia

Phase 1
Waitlist Available
Led By Adam J Lamble
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory after 2 or more chemotherapy cycles
Patients must weigh >/= 17 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of flotetuzumab, an immunotherapy, for treating patients with recurrent or refractory acute myeloid leukemia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system since flotetuzumab is an immunotherapy drug. These may involve inflammation in various organs or changes in normal immune responses. Specific side effect details are under investigation within this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve after 2 or more chemotherapy cycles.
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I weigh at least 17 kilograms.
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I have a central line with two lumens installed for treatment.
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My condition has worsened or returned after treatment at least twice.
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I can care for myself but may not be able to do heavy physical work.
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It's been over 2 weeks since my last chemotherapy, and I've recovered from its side effects.
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I have received special chemotherapy to treat cancer in my brain or spinal cord before joining this study.
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My weight fits the current drug's formulation limits.
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My first relapse occurred after a stem cell transplant.
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I weigh at least 17 kilograms.
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I haven't taken any cancer medication that lowers blood counts in the last 7 days.
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My leukemia is advanced, and I've had multiple treatments or a relapse after a stem cell transplant.
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My current condition has no cure or treatment to extend life with good quality.
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My AML cancer has come back or is not responding to treatment, and this was confirmed by a lab test.
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My cancer has returned after not responding to the first chemotherapy.
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My kidney function is within the required range for my age and gender.
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I had CNS disease but now have no signs of it on scans.
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My AML cancer has returned or is not responding to treatment, confirmed by tests.
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My bilirubin levels are within the normal range for my age.
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I have never been treated with flotetuzumab.
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I don't have brain-related symptoms or signs of leukemia in my nervous system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities Due to Flotetuzumab
Maximum Tolerated Dose or Recommended Phase 2 Dose of Flotetuzumab
Secondary outcome measures
Antitumor Activity of Flotetuzumab
Maximum Concentration (C Max)
Other outcome measures
CD123 Surface Expression
Change in T-lymphocyte Population Numbers

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (flotetuzumab, cytarabine)Experimental Treatment2 Interventions
Patients 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. Patients also 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,630 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,384 Total Patients Enrolled
Adam J LamblePrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Media Library

Flotetuzumab (Bispecific Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT04158739 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment (flotetuzumab, cytarabine)
Acute Myelogenous Leukemia Clinical Trial 2023: Flotetuzumab Highlights & Side Effects. Trial Name: NCT04158739 — Phase 1
Flotetuzumab (Bispecific Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04158739 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What measurable results is this clinical trial attempting to obtain?

"The main objective of this experiment, to be completed within a month's time frame, is to determine the dose-limiting toxicities caused by flotetuzumab. Secondary objectives include assessing the maximum concentration and area under the curve for plasma concentrations at steady state, as well as measuring anti-tumor activity through determining frequency and percentages of patients who experience partial responses."

Answered by AI

What is the cap on participation in this research endeavor?

"This clinical trial has closed its recruitment period, initiating on June 1st 2020 and concluding most recently on October 7th 2022. If you're interested in other studies, there are 1466 trials searching for leukemic patients and 236 recruiting participants who hope to try Flotetuzumab."

Answered by AI

Have any prior investigations utilized Flotetuzumab?

"At present, there are 236 active trials on Flotetuzumab with 60 in the third phase. These studies are primarily situated in New york City, though a total of 9791 sites worldwide have been used for testing this medication."

Answered by AI

For which conditions is Flotetuzumab employed therapeutically?

"Flotetuzumab is a viable treatment option for leptomeningeal metastases, acute promyelocytic leukemia, and meningeal leukemia."

Answered by AI

Are there various health centers conducting this research project in the city?

"This medical trail is running out of 19 different sites, including Children's National Medical Center in Washington D.C., Lurie Chidren's Hospital-Chicago in Chicago, Illinois, and Washington University School fo Medicine in Saint Louis Missouri."

Answered by AI

Is participation in this experiment open to more volunteers?

"The posting on clinicaltrials.gov indicates that this particular medical trial is no longer enrolling patients. It was initially published on June 1st 2020 and since then has had its last update on October 7th 2022. Fortunately, there are currently 1702 other trials seeking participants at the moment."

Answered by AI

Has Flotetuzumab been granted official authorization by the FDA?

"The level of safety associated with Flotetuzumab is currently rated at 1. This rating was assigned since the medication is in its initial trial phase, thus there are limited clinical studies validating both its efficacy and security."

Answered by AI
~3 spots leftby Mar 2025