Not recruiting

Study on Gemtuzumab Ozogamicin and Gilteritinib for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in patients whose disease has returned or is not responding to treatment. The study is testing a combination of two medications: Gemtuzumab Ozogamicin, known by the brand name Mylotarg, and Gilteritinib, known by the brand name Xospata. Gemtuzumab Ozogamicin is given as an infusion, which means it is administered directly into the bloodstream, while Gilteritinib is taken as a tablet by mouth.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment in adults with a specific genetic mutation in their leukemia cells called FLT3-ITD. The study is divided into two stages. In the first stage, the focus is on assessing the safety of adding Gilteritinib to the existing treatment plan. In the second stage, the study aims to determine how well the combination works in preventing the cancer from worsening or returning.

Participants in the study will receive the combination treatment and will be monitored for any side effects and how their disease responds to the treatment. The study will also look at how long patients live without the disease getting worse and other outcomes related to their health and quality of life. The trial is expected to continue until 2028, with the goal of providing valuable information on the potential benefits of this treatment combination for patients with relapsed or refractory AML.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of acute myeloid leukemia (AML), and presence of certain genetic mutations.
The study is designed for adults with relapsed or refractory AML with a specific mutation known as FLT3-ITD.
Step 2
Stage 1: safety assessment
The first stage focuses on evaluating the safety of combining two medications: gemtuzumab ozogamicin and gilteritinib.
Gemtuzumab ozogamicin is administered as a solution for infusion, which means it is given intravenously.
Gilteritinib is taken orally in the form of film-coated tablets.
The primary goal is to identify any dose-limiting toxicities, which are side effects that prevent further increase in dosage.
Step 3
Stage 2: efficacy assessment
The second stage evaluates the effectiveness of the medication combination in improving event-free survival, which refers to the time during and after treatment that a patient remains free from certain complications or events.
This stage continues to monitor the safety of the treatment.
Step 4
Medication administration
Gemtuzumab ozogamicin is given as an infusion, which involves receiving the medication directly into the bloodstream through a vein.
Gilteritinib is taken orally, with the dosage and frequency determined by the study protocol.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the patient's response to the treatment and to identify any side effects.
This includes routine blood tests and other assessments as required by the study protocol.
Step 6
Completion of the trial
The trial is expected to continue until June 2028, with ongoing assessments of safety and efficacy.
Upon completion, the results will contribute to understanding the potential benefits and risks of the treatment combination for patients with relapsed or refractory AML.

Who can join the trial?

7 criteria

Patients must be **18 years old or older**.
Must have a confirmed diagnosis of **R/R AML** (a type of leukemia) that is positive for **CD33 antigen**. This means the leukemia has not responded to treatment or has returned after treatment.
Must have a **FLT3-ITD mutation** or a **FLT3 TKD mutation**. These are specific changes in the leukemia cells.
Must not have any medical reasons that prevent them from taking the medications **gemtuzumab ozogamicin (GO)**, **cytarabine**, and **gilteritinib**.
Must have an **ECOG performance status** of **2 or less**. This is a scale that measures how well a patient can perform daily activities.
**AST and ALT** levels must be **2.5 times or less** than the normal upper limit, and **bilirubin** levels must be **1.5 times or less** than the normal upper limit, unless these levels are high due to leukemia.
Must have an **estimated glomerular filtration rate (GFR)** of **50 mL/min or more**. This is a measure of how well the kidneys are working.

Who cannot join the trial?

6 criteria

Patients who do not have a diagnosis of Acute Myeloid Leukemia cannot participate. Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow.
Patients who do not have the specific genetic mutation called FLT3-ITD in their leukemia cells are excluded. This is a change in the DNA that can affect how the leukemia behaves.
Patients who are not between the ages of 3 and 4 years old are excluded.
Patients who are not part of the specific clinical trial group coded as "2" are excluded.
Both male and female patients are eligible, so gender does not exclude participation.
Patients who are considered part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Gemtuzumab Ozogamicin
is a medication used in this study to treat a type of blood cancer called acute myeloid leukemia (AML). It works by attaching to cancer cells and delivering a substance that helps kill them. This medication is part of the treatment combination being tested in the trial.
Gilteritinib
is another medication used in the study. It is designed to target and block specific proteins that help cancer cells grow, particularly in patients with a mutation known as FLT3-ITD. This medication is being combined with others to see if it improves treatment outcomes for patients with AML.
Cytarabine
is a chemotherapy drug included in the treatment combination. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This medication is commonly used in the treatment of various types of leukemia, including AML.

What is already known about the treatment

Gemtuzumab Ozogamicin
This medication is administered intravenously and is currently being studied in combination with other drugs for its effectiveness in treating acute myeloid leukemia (AML), particularly in cases that are resistant or have relapsed. It is an antibody-drug conjugate that targets specific cancer cells, delivering a toxic agent directly to them. This targeted approach helps to minimize damage to healthy cells. Gemtuzumab Ozogamicin is classified as an antineoplastic agent.
Gilteritinib
This medication is taken orally and is being evaluated for its safety and effectiveness in combination with other treatments for acute myeloid leukemia (AML) with a specific genetic mutation known as FLT3-ITD. It works by inhibiting certain enzymes that promote the growth of cancer cells, thereby slowing down or stopping the progression of the disease. Gilteritinib is classified as a tyrosine kinase inhibitor.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease progresses quickly and requires prompt medical attention. It is more common in adults and can vary in its specific genetic mutations, which can influence the course of the disease. AML is classified into different subtypes based on the characteristics of the leukemia cells.