Not recruitingRare disease

Study on Venetoclax, Azacitidine, and Cusatuzumab for Newly Diagnosed Acute Myeloid Leukemia Patients Not Suitable for Intensive Therapy

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 study is designed for patients who have been newly diagnosed with AML and are not suitable for intensive therapy. The trial will explore the effectiveness of adding a medication called Cusatuzumab to a treatment combination of Venetoclax and Azacitidine, compared to using Venetoclax and Azacitidine alone. Venetoclax is available in tablet form, while Azacitidine is given as an injection. Cusatuzumab, also known by its code name OV-1001, is administered through an infusion, which means it is delivered directly into the bloodstream.

The purpose of this study is to determine if adding Cusatuzumab to the existing treatment of Venetoclax and Azacitidine can improve outcomes for patients with AML. Participants in the study will be randomly assigned to receive either the combination of Venetoclax, Azacitidine, and Cusatuzumab or just Venetoclax and Azacitidine. The study will monitor various health outcomes, including overall survival and the rate of complete remission, which is when there are no signs of cancer in the body. The trial will also track any side effects or adverse events that participants may experience during the treatment period.

The study will take place over several years, with an estimated completion date in 2026. Participants will receive regular check-ups and monitoring throughout the trial to ensure their safety and to assess the effectiveness of the treatment. The trial aims to provide valuable information on whether the addition of Cusatuzumab can offer better treatment options for patients with AML who are unable to undergo more intensive therapies.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and other laboratory evaluations are performed to ensure adequate liver and kidney function.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving venetoclax and azacitidine with cusatuzumab, and the other receiving venetoclax and azacitidine alone.
Step 3
Treatment initiation
Treatment begins with the administration of venetoclax and azacitidine. Venetoclax is taken orally in the form of film-coated tablets, with dosages of 10 mg, 50 mg, or 100 mg as prescribed by the study protocol.
Azacitidine is administered as a subcutaneous injection, with the dosage and frequency determined by the study protocol.
Step 4
Cusatuzumab administration
For participants in the group receiving cusatuzumab, this medication is given intravenously as a concentrate for solution for infusion. The schedule and dosage are specified in the study protocol.
Step 5
Ongoing monitoring
Regular monitoring is conducted throughout the study to assess the effectiveness and safety of the treatment. This includes blood tests, physical examinations, and other necessary evaluations.
Participants are monitored for any adverse events or side effects, and adjustments to the treatment may be made as needed.
Step 6
Completion of treatment
The treatment phase continues until the study's end date or until the participant completes the prescribed treatment duration.
Final assessments are conducted to evaluate the overall response to the treatment and to gather data on the primary and secondary endpoints of the study.

Who can join the trial?

9 criteria

Men and women who are **18 years old or older**.
Must sign an **informed consent form** to show they understand the study and agree to participate.
Must have a diagnosis of **acute myeloid leukemia (AML)**, a type of blood cancer, according to specific guidelines, but not a type with 10-19% blasts.
Must not have received treatment for AML before, except for emergency procedures to control high white blood cell counts.
Must be considered **unfit for intensive chemotherapy** based on specific criteria.
Must have **adequate liver and kidney function** as defined in the study guidelines.
Women who can have children must have a **negative pregnancy test** before starting the study.
Must be willing to use **contraception** as per the study's guidelines.
Participants with **HIV infection** can join if they meet specific criteria.

Who cannot join the trial?

9 criteria

Patients with other types of cancer besides acute myeloid leukemia cannot participate. Acute myeloid leukemia is a type of blood cancer.
Patients who are not within the specified age range for the study cannot participate. The study is for adults.
Patients who are pregnant or breastfeeding cannot participate.
Patients with severe uncontrolled infections cannot participate. This means infections that are not being managed well with treatment.
Patients who have received certain treatments recently that might interfere with the study cannot participate.
Patients with significant heart problems cannot participate. This includes conditions that affect how well the heart works.
Patients with severe liver or kidney problems cannot participate. These are conditions where the liver or kidneys are not working properly.
Patients who have had a recent major surgery cannot participate. Major surgery refers to operations that are more complex and involve significant recovery time.
Patients who are unable to follow the study procedures cannot participate. This means they might have difficulty understanding or completing the study requirements.

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Verified sites

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

Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Verified
Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Venetoclax
is a medication used to help treat certain types of blood cancers. It works by targeting and blocking a specific protein that cancer cells need to survive, which can help to kill the cancer cells and slow down the progression of the disease.
Azacitidine
is a medication that is used to treat certain blood disorders and cancers. It works by interfering with the growth of cancer cells, which can help to stop them from multiplying and spreading.
Cusatuzumab
is an experimental medication being studied for its potential to treat certain types of blood cancers. It is designed to target and bind to a specific protein found on the surface of cancer cells, which may help the immune system to recognize and destroy these cells.

What is already known about the treatment

Venetoclax
Venetoclax is administered orally in the form of tablets. It is currently used in the treatment of certain types of blood cancers, including acute myeloid leukemia (AML). The medication works by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor.
Azacitidine
Azacitidine is given as an injection under the skin or into a vein. It is used in the treatment of various blood disorders, including acute myeloid leukemia (AML). Azacitidine works by incorporating into the DNA of cancer cells, disrupting their growth and leading to cell death. It is classified as a nucleoside metabolic inhibitor.
Cusatuzumab
Cusatuzumab is administered through intravenous infusion. It is an investigational drug currently being studied for its potential use in treating acute myeloid leukemia (AML). Cusatuzumab targets a specific protein on the surface of cancer cells, aiding the immune system in recognizing and destroying these cells. It is classified as a monoclonal antibody.

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. This leads to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. AML can occur at any age but is more common in adults. The disease progresses rapidly, requiring prompt medical attention. The exact cause of AML is not fully understood, but it involves genetic mutations in the blood cells.