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Study of gemtuzumab ozogamicin with chemotherapy for adults aged 18-60 with newly diagnosed favorable-intermediate-risk acute myeloid leukemia

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What is this trial about?

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

This study focuses on adult patients with Acute Myeloid Leukemia (AML), a blood cancer where abnormal cells grow in the bone marrow. The study examines a treatment combining Gemtuzumab Ozogamicin (also known as Mylotarg) with standard chemotherapy drugs including Daunorubicin, Fludarabine, Busulfan, Cytarabine, Treosulfan, and Cyclophosphamide.

The purpose of this research is to determine how effective Gemtuzumab Ozogamicin is when used together with standard chemotherapy in treating patients who have not received previous treatment for their AML. The study specifically looks at how well this combination reduces the number of cancer cells that remain in the body after treatment.

During the study, participants receive the medications through an intravenous infusion (given directly into a vein). The treatment consists of multiple phases, including initial treatment (induction) and additional treatment to maintain results (consolidation). Patients will be monitored for approximately 24 months to evaluate how well the treatment works and to check for any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase (Induction)
You will receive a combination of medications through intravenous infusion (directly into your vein).
The medications include gemtuzumab ozogamicin (Mylotarg) together with standard chemotherapy drugs: daunorubicin and cytarabine.
This phase aims to achieve initial remission of the blood cancer (acute myeloid leukemia).
Step 2
Treatment response evaluation
Your doctor will perform a bone marrow examination to check how well the treatment is working.
The main goal is to measure the levels of remaining cancer cells, known as minimal residual disease (MRD).
Step 3
Consolidation treatment phase
If the initial treatment is successful, you will receive additional therapy to maintain the results.
The consolidation treatment includes fludarabine, busulfan, treosulfan, and cyclophosphamide, administered through intravenous infusion.
After this phase, another bone marrow examination will be performed to check MRD levels.
Step 4
Follow-up period
Your health status will be monitored for 24 months after treatment completion.
Regular check-ups will assess your overall health and track any potential return of the disease.
The study will continue until March 2027.
Step 5
Safety monitoring
Throughout the entire study period, you will be monitored for any side effects or health changes.
Regular heart function tests will be performed to ensure your heart ejection fraction remains at safe levels.
Blood tests will be conducted to monitor your kidney and liver function.

Who can join the trial?

12 criteria

Age must be between 18 and 60 years
Must sign written informed consent to participate in the study
Must not have any psychological, family, social, or geographical conditions that could interfere with following the study schedule
For women who can become pregnant: must have a negative pregnancy test within 48 hours before starting treatment. Women who have not had periods for at least 12 months are considered unable to become pregnant
All participants must agree to use effective birth control during the study and for 6 months after stopping the study medicine
Must not have received previous treatment for Acute Myeloid Leukemia (AML), except for up to 14 days of hydroxyurea (a medication to control blood cell counts)
Must have a confirmed new diagnosis of AML with at least 20% blast cells (immature blood cells) in bone marrow
Must have favorable-intermediate risk AML according to medical guidelines, excluding certain genetic mutations (FLT3-ITD/TKD)
Must have a performance status of 0-3 (a measure of daily living abilities)
Must have adequate kidney function (creatinine levels) and liver function (bilirubin, ALT, and AST levels)
Must have good heart function with ejection fraction of 50% or higher (measured by heart ultrasound)
Must not have severe neurological or psychiatric diseases, heart failure, or active uncontrolled infections

Who cannot join the trial?

13 criteria

Patients with unfavorable risk Acute Myeloid Leukemia (high-risk forms of blood cancer)
Patients younger than 18 years old
Patients with active heart problems or severe heart disease
Patients with severe kidney dysfunction (poor kidney function)
Patients with severe liver dysfunction (poor liver function)
Patients with active uncontrolled infections
Patients who received chemotherapy within the last 2 weeks
Patients with known allergies to gemtuzumab ozogamicin (study medication) or similar drugs
Pregnant or breastfeeding women
Patients participating in other clinical trials
Patients with psychiatric conditions that could interfere with study compliance
Patients with uncontrolled high blood pressure
Patients with active secondary cancers

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Verified sites

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Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy

Trial locations

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Investigated drugs

Gemtuzumab ozogamicin is a targeted cancer medication used to treat acute myeloid leukemia (AML). It works by attaching to specific proteins found on cancer cells and delivering a substance that kills these cells. It is designed to work together with standard chemotherapy to help destroy leukemia cells more effectively and reduce the amount of cancer cells remaining in the body after treatment. Standard chemotherapy refers to traditional cancer-fighting medications that work by killing rapidly dividing cells in the body, including cancer cells. In this trial, it is used as the foundation of treatment and is combined with gemtuzumab ozogamicin to potentially improve treatment outcomes for patients with acute myeloid leukemia.

What is already known about the treatment

Gemtuzumab ozogamicin - An antibody-drug conjugate administered intravenously for the treatment of acute myeloid leukemia (AML). The medication combines a targeted antibody that recognizes CD33 protein on leukemia cells with a powerful chemotherapy agent, allowing for precise delivery of the drug to cancer cells. It works by binding to CD33-positive leukemia cells and releasing the toxic component inside them, leading to cell death, while minimizing damage to healthy cells. This targeted therapy is classified as a monoclonal antibody conjugated with cytotoxic agent, and is typically used in combination with standard chemotherapy for treating adults with newly diagnosed favorable or intermediate-risk AML.

Investigated diseases

Acute Myeloid Leukemia (Favorable-Intermediate Risk) - A blood and bone marrow cancer that develops when young blood cells called myeloid cells begin growing abnormally. In this particular form, genetic and molecular features indicate a more favorable or intermediate outlook compared to other types. The disease progresses relatively quickly as abnormal white blood cells accumulate in the bone marrow and interfere with normal blood cell production. These leukemia cells eventually spread into the bloodstream and can affect other parts of the body. This condition specifically affects the myeloid line of blood cells, which normally develop into various types of mature blood cells, including red blood cells, platelets, and certain white blood cells.