RecruitingRare disease

Study on Midostaurin and Gemtuzumab Ozogamicin for Adults with Acute Myeloid Leukemia

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 treatments for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study involves a combination of medications, including Midostaurin, Gemtuzumab Ozogamicin, Cytarabine, and Daunorubicin Hydrochloride. These medications are used in different forms, such as soft capsules and solutions for infusion, which are administered intravenously or orally.

The purpose of the study is to evaluate how well the combination of Midostaurin and Gemtuzumab Ozogamicin works when used with standard chemotherapy for treating newly diagnosed AML. Participants will receive these treatments as part of their first-line therapy, which means it is the first set of treatments given for their condition. The study will monitor the tolerability, which refers to how well patients can handle the treatment, and the efficacy, which means how effective the treatment is in managing the disease.

Throughout the study, participants will receive the medications in a structured manner, with some receiving a placebo for comparison. The trial will assess the maximum tolerated dose of the medications and track the event-free survival of participants, which is the time they remain free from treatment failure, relapse, or death. The study aims to provide valuable insights into the potential benefits of this combination therapy for patients with 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, the patient will provide written informed consent. This is a document that confirms understanding and agreement to participate in the trial.
The patient must be newly diagnosed with acute myeloid leukemia (AML) and meet specific genetic criteria as outlined by the study.
Step 2
Initial assessment
An initial assessment will be conducted to ensure the patient meets all eligibility criteria, including age, health status, and specific genetic markers related to AML.
Step 3
Treatment phase I
The patient will receive a combination of medications to evaluate the maximum tolerated dose. This includes midostaurin and gemtuzumab ozogamicin administered intravenously.
The goal is to determine the highest dose that can be given without causing severe side effects.
Step 4
Treatment phase II
In this phase, the patient will continue to receive the combination of midostaurin and gemtuzumab ozogamicin along with standard AML induction chemotherapy.
The medications include cytarabine and daunorubicin hydrochloride, both administered intravenously, and midostaurin taken orally as soft capsules.
The treatment aims to improve event-free survival, which means delaying or preventing treatment failure, relapse, or death.
Step 5
Monitoring and follow-up
Throughout the trial, the patient's health and response to treatment will be closely monitored.
Regular follow-up visits will be scheduled to assess the effectiveness and any side effects of the treatment.
Step 6
Completion of the trial
The trial is expected to continue until September 2029, with ongoing assessments to determine the long-term effects and benefits of the treatment combination.

Who can join the trial?

7 criteria

Must provide written informed consent, which means you agree to participate after understanding the study details.
Must have been newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer, according to specific medical criteria.
Must be a male or female aged between 18 and 75 years for one part of the study, and between 18 and 70 years for other parts.
Must have an ECOG Score of 0-2, which is a measure of your ability to perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
Must have a life expectancy of more than 14 days.
Must have adequate liver and kidney function, meaning your liver and kidneys are working well enough. This is checked by specific blood tests.
Must have a white blood cell count of less than 30 x 10⁹/L. If needed, certain medications can be used to help meet this requirement.

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Verified sites

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

Goethe University Frankfurt
Verified
Frankfurt, Germany
Klinikum Nuernberg
Verified
Nürnberg, Germany
Klinikum der Universitaet Muenchen AöR
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Munich, Germany

Trial locations

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Investigated drugs

Midostaurin
is a medication used in this trial to help treat acute myeloid leukemia (AML). It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the progression of the disease.
Gemtuzumab Ozogamicin
is another medication used in the trial. It is a type of targeted therapy that combines an antibody with a chemotherapy drug. This combination helps deliver the chemotherapy directly to the cancer cells, potentially reducing damage to healthy cells and improving the effectiveness of the treatment.

What is already known about the treatment

Midostaurin
This medication is administered orally and is currently being studied in combination with other treatments for acute myeloid leukemia (AML) in adults. It is approved for use in certain types of leukemia and is well-documented in medical literature. Midostaurin is primarily used to treat specific genetic mutations in leukemia cells. It works by inhibiting certain proteins that promote cancer cell growth, classifying it as a tyrosine kinase inhibitor.
Gemtuzumab Ozogamicin
This medication is given intravenously and is used in the treatment of acute myeloid leukemia (AML) in adults. It is an established treatment option and is well-represented in medical literature. Gemtuzumab Ozogamicin targets specific proteins on leukemia cells, delivering a toxic agent directly to the cancer cells, which helps to destroy them. It is classified as an antibody-drug conjugate.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. 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. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. AML can progress rapidly, requiring prompt medical attention. The disease is more common in adults and can vary in its specific genetic mutations, which may influence its behavior and response to treatment.