Study on the Safety and Effectiveness of Luveltamab Tazevibulin (STRO-002) for Infants and Children Under 12 with Acute Myeloid Leukemia (AML)

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What is this study about?

This clinical trial is focused on studying a specific type of blood cancer called Acute Myeloid Leukemia (AML) in infants and children under 12 years old. The trial is investigating a treatment using a drug called Luveltamab Tazevibulin (STRO-002), which is given as a solution through a vein, known as an infusion. This study aims to understand how safe and effective this drug is for young patients with this particular type of leukemia.

Participants in the study will receive the drug Luveltamab Tazevibulin to see how it affects their condition. The study will monitor the participants over time to observe the drug’s effects on their leukemia, including how well it works and any side effects that may occur. The study will also measure how long the drug stays in the body and how the body responds to it.

The main goal of the study is to evaluate the effectiveness of Luveltamab Tazevibulin when used alone, without other treatments. Researchers will look at various outcomes, such as the rate of complete remission, which means the disappearance of all signs of cancer in response to treatment. They will also assess how long the remission lasts, the overall survival of the participants, and any adverse effects experienced during the trial. This information will help determine the potential benefits and risks of using this drug in young patients with AML.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. If applicable, a pediatric assent form will also need to be signed.

If you have reached puberty, you will receive reproductive education and discuss the potential effects of the study therapy on reproduction with your parent(s) or guardian(s).

2 initial health assessments

A series of health assessments will be conducted to confirm your eligibility. This includes a diagnosis of relapsed or refractory acute myeloid leukemia (AML) with a specific genetic marker.

A lumbar puncture will be performed to check for central nervous system involvement. Other tests will include blood tests to check liver and kidney function, heart function tests, and a pregnancy test if applicable.

3 treatment administration

You will receive the study drug, luveltamab tazevibulin (STRO-002), as a solution for infusion. This means the medication will be given through a vein.

The dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare team.

4 monitoring and follow-up

Throughout the study, regular monitoring will be conducted to assess your response to the treatment and to check for any side effects.

This will include blood tests, imaging studies, and other necessary evaluations as determined by your healthcare team.

5 end of treatment

At the end of the treatment period, a final set of assessments will be conducted to evaluate the overall effectiveness of the therapy and your health status.

You will be advised on any necessary follow-up care or additional treatments based on the study findings and your individual health needs.

Who Can Join the Study?

Must sign an informed consent form. If the participant is a child, a parent or guardian must also sign a form.
Females who have started menstruating and males who have reached puberty must agree to receive education about reproduction and discuss potential side effects of the study treatment on reproduction with their parents or guardians.
Females who have started menstruating must have a negative pregnancy test within 7 days before the first dose of the study drug. All participants who have reached puberty and are sexually active must agree to use condoms during heterosexual contact. Females may also use other birth control methods if advised by their doctor. Pregnancy prevention must continue during the study, during any breaks in treatment, and for at least 6 months after stopping the study drug.
Must have a diagnosis of relapsed or refractory Acute Myeloid Leukemia (AML) with a specific genetic change called CBFA2T3::GLIS2 fusion. The disease must have returned or not responded to treatment, with at least 5% of the bone marrow affected by leukemia. A lumbar puncture is required at screening to check for disease in the central nervous system (CNS). Participants with certain CNS conditions (CNS1 and CNS2) are eligible.
Must be younger than 12 years old.
Must have a Lansky performance score of 50 or higher, which measures the ability to perform daily activities.
Must have a direct bilirubin level less than 1.5 times the upper limit of normal. This is a liver function test. Participants with Gilbert’s disease must also meet this requirement.
Must have ALT and AST levels less than 2.5 times the upper limit of normal, unless related to leukemia. These are liver enzymes. Participants with liver involvement may have levels up to 5 times the upper limit.
Must have a creatinine clearance or glomerular filtration rate of 70 or higher, or a serum creatinine level based on age and gender. These tests measure kidney function.
Must have a corrected QT interval (QTcF) of less than 450 milliseconds. This is a heart rhythm measurement.
Must have a left ventricular ejection fraction greater than 50% as measured by an echocardiogram (ECHO). This measures how well the heart pumps blood.

Who Cannot Join the Study?

Patients with any other active cancer besides Acute Myeloid Leukemia (AML) cannot participate.
Patients who have received another investigational drug within the last 30 days are excluded.
Patients with uncontrolled infections are not eligible.
Patients with severe heart problems, such as heart failure or recent heart attack, cannot join the study.
Patients with severe liver disease are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of allergic reactions to similar drugs are not eligible.
Patients with a history of drug or alcohol abuse within the last year are excluded.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
St. Anna Kinderspital GmbH	Vienna	Austria
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Udelmgpkjrzjkfgvshkdf Eybpb Agh	Essen	Germany
Hbyzvpas Vcry dmklzxvv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2024
Denmark	Not recruiting	01.09.2024
France	Not recruiting	01.09.2024
Germany	Not recruiting	01.09.2024
Italy	Not recruiting	01.09.2024
Spain	Not recruiting	01.09.2024
The Netherlands	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Stro-002

Luveltamab Tazevibulin (STRO-002) is a medication being studied for its potential to treat a specific type of leukemia in young children. This medication is designed to target and attack cancer cells in the body, helping to stop their growth and spread. The goal of using this medication in the trial is to see how effective it is in treating the leukemia and to understand its safety and how it behaves in the body. By focusing on this medication, researchers hope to find a new treatment option for children with this type of cancer.

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The disease progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they can spread to other parts of the body, including the liver, spleen, and central nervous system. The progression of AML can vary, with some cases advancing more rapidly than others. The disease requires medical attention to manage its effects on the body.

Trial ID:

2023-506240-16-00

Protocol code:

REFRaME-P1

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Luveltamab Tazevibulin (STRO-002) for Infants and Children Under 12 with Acute Myeloid Leukemia (AML)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?