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Study of Dasatinib for Patients with Acute Myeloid Leukemia Not Responding to Venetoclax-Azacitidine Treatment

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). The trial is specifically for patients whose AML has not responded to a previous treatment combination of venetoclax and azacitidine. The treatment being tested in this study is a medication called dasatinib, which is taken as a film-coated tablet. Dasatinib is known as a kinase inhibitor, which means it works by blocking certain proteins that help cancer cells grow.

The purpose of the study is to evaluate how well dasatinib works on its own in treating patients with AML who did not respond to the previous treatment. Participants in the study will receive dasatinib for a period of time, and the researchers will monitor how the cancer responds to the treatment. The study will look at how many patients achieve complete remission, which means the cancer is no longer detectable, or partial remission, where the cancer is reduced but not completely gone. The study will also track how long patients stay in remission and their overall survival during the study period.

Throughout the study, the safety of dasatinib will be closely monitored, and any side effects will be recorded. The trial aims to provide valuable information on the effectiveness of dasatinib as a treatment option for patients with AML who have limited options due to their cancer not responding to other treatments. The study is expected to continue until 2025, with the goal of improving treatment outcomes for patients with this challenging form of leukemia.

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
Joining the study
Participation begins after meeting specific criteria, including a confirmed diagnosis of acute myeloid leukemia (AML), age of 18 years or older, and a lack of response to previous VENETOCLAX-AZACITIDINE treatment.
Consent is required, and participants must be affiliated with a social security system.
Step 2
Treatment initiation
The treatment involves taking dasatinib as a monotherapy. This medication is administered orally in the form of film-coated tablets.
The available dosages are 50 mg and 70 mg tablets.
Step 3
Treatment cycles
The treatment is structured in cycles, each lasting 28 days.
The main objective is to evaluate the tumor response after two cycles of dasatinib treatment.
Step 4
Evaluation of response
The primary endpoint is to determine the objective response rate, which includes complete remission or complete remission with incomplete hematologic recovery.
Secondary endpoints include various response rates, time to response, duration of relapse-free period, event-free survival, overall survival, and the occurrence of adverse events.
Step 5
Monitoring and follow-up
Participants are monitored for any adverse events and their overall health status throughout the trial.
The trial is expected to continue until October 30, 2025.

Who can join the trial?

6 criteria

Must have a confirmed diagnosis of **acute myeloid leukemia (AML)**, but not the type called Philadelphia chromosome-positive AML (Ph+) or acute promyelocytic leukemia (AML M3).
Must be **18 years or older**.
Must have an **ECOG score of 3 or less**. ECOG is a scale used to assess how a disease affects a patient's daily living abilities, with lower numbers indicating better function.
Must be **refractory to VEN-AZA therapy**, meaning there was no response after two cycles of this treatment, regardless of the dose or how long it was given.
Must have **signed an informed consent form**, which means agreeing to participate in the study after being informed about it.
Must be **affiliated with a social security system** or be a beneficiary of such a system.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than acute myeloid leukemia cannot participate. Acute myeloid leukemia is a type of blood cancer.
Patients who are eligible for chemotherapy treatment cannot join the study. This means if a patient can safely receive chemotherapy, they are not allowed to participate.
Patients who have not previously been treated with VEN-AZA therapy cannot participate. VEN-AZA therapy is a specific treatment for certain types of leukemia.
Patients who are under 18 years old or over 65 years old cannot participate. The study is only for adults between these ages.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not allowed to participate.

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Verified sites

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

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Centre Hospitalier Universitaire De Nice
Nice, France
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Institut Paoli-Calmettes Cancer Centre
Marseille, France
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Oncopole Claudius Regaud
Toulouse, France

Trial locations

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Investigated drugs

Dasatinib
is a medication being tested in this trial for its effectiveness in treating patients with acute myeloid leukemia who have not responded to previous treatments. It is used as a monotherapy, meaning it is given alone without combining it with other drugs. The goal is to see how well it can reduce or eliminate cancer cells after two cycles of treatment.
Venetoclax
and Azacitidine are medications that were previously used in patients participating in this trial. These patients did not respond to this combination therapy, which is why they are now being treated with Dasatinib. Venetoclax works by helping to kill cancer cells, while Azacitidine helps to stop the growth of cancer cells.

Dasatinib

What is already known about the treatment

Dasatinib – Dasatinib is administered orally in tablet form and is currently being studied for its effectiveness in treating acute myeloid leukemia, particularly in patients who do not respond to standard treatments like Venetoclax and Azacitidine. It is classified as a tyrosine kinase inhibitor, which works by blocking specific proteins that promote the growth of cancer cells. This medication is primarily used in the treatment of certain types of leukemia, and its role in acute myeloid leukemia is under investigation in clinical trials.

Investigated diseases

Acute Myeloid Leukemia – Acute myeloid leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of abnormal white blood cells that interfere with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease is characterized by the presence of immature white blood cells, known as myeloblasts, in the blood and bone marrow. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression of acute myeloid leukemia can vary, but it typically requires prompt medical attention.