Not recruiting

Study of Venetoclax and Azacitidine for Adults 18+ with Acute Myeloid Leukemia Not Eligible for Standard Therapy

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 testing a combination of two medications: Venetoclax and Azacitidine. Venetoclax is taken as a tablet, while Azacitidine is given as an injection. The study is designed for patients who are newly diagnosed with AML, are 18 years or older, and are not eligible for the usual intensive chemotherapy due to age or other health conditions.

The purpose of the study is to gather initial information on how effective the combination of Venetoclax and Azacitidine is for this group of patients. Participants in the study will receive Venetoclax tablets and Azacitidine injections over a period of up to six months. The study will monitor how well the treatment works and how the patients respond to it. The trial is open-label, meaning both the researchers and participants know which treatments are being administered.

Throughout the study, various aspects will be observed, such as the response of the leukemia to the treatment, the time it takes for the treatment to show effects, and the overall survival of the participants. The study will also look at the quality of life of the patients during the treatment period. This trial aims to provide valuable insights into the potential benefits of this treatment combination for patients with AML who have limited treatment options.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, the treatment begins with the administration of two medications: venetoclax and azacitidine.
Venetoclax is taken orally in the form of a film-coated tablet called Venclyxto 100 mg. The dosage and frequency will be determined by the study team based on individual needs.
Azacitidine is administered as a subcutaneous injection, which means it is injected under the skin. The product used is called Vidaza 25 mg/ml powder for suspension for injection.
Step 2
Treatment cycle
The treatment is organized into cycles. Each cycle includes 5 days of azacitidine administration.
The study aims to evaluate the response to the treatment over a period of up to 6 cycles. The response is measured by the rate of complete remission (CR) or complete remission with incomplete blood count recovery (CRi).
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.
These assessments may include blood tests, physical examinations, and questionnaires to measure quality of life.
Step 4
End of treatment
The trial is expected to continue until December 1, 2024, unless the treatment is discontinued earlier due to specific reasons such as achieving the desired response or experiencing significant side effects.
The study team will provide guidance on the next steps after the trial concludes.

Who can join the trial?

4 criteria

Confirmed diagnosis of Acute Myeloid Leukemia (AML) by WHO criteria 2016 and not eligible for standard treatment due to age or other health conditions.
Age 18 years or older.
Expected to live for at least 12 more weeks.
Have good enough kidney and liver function.

Who cannot join the trial?

3 criteria

Patients who do not have acute myeloid leukemia cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany
Technische Universitaet Dresden
Verified
Dresden, Germany
Universitaet Leipzig
Verified
Leipzig, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Venetoclax
is a medication used in this trial to help treat acute myelogenous leukemia, a type of blood cancer. It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, Venetoclax can help kill the cancer cells and slow down the progression of the disease.
Azacitidine
is another medication used in combination with Venetoclax in this trial. It is designed to help treat acute myelogenous leukemia by interfering with the growth of cancer cells. Azacitidine works by incorporating itself into the DNA of the cancer cells, which can disrupt their ability to grow and divide. This can help reduce the number of cancer cells in the body and improve the patient's condition.

What is already known about the treatment

Venetoclax
Venetoclax is taken orally in the form of tablets and is currently being studied in combination with Azacitidine for treating acute myeloid leukemia, particularly in patients who are 18 years or older and not eligible for standard induction therapy. It works by targeting and inhibiting a specific protein in cancer cells, which helps to trigger the death of these cells. Venetoclax is classified as a BCL-2 inhibitor, a type of medication that helps to manage certain types of blood cancers.
Azacitidine
Azacitidine is administered through injection and is being evaluated in combination with Venetoclax for its effectiveness in treating acute myeloid leukemia in patients who are not suitable for standard induction therapy. It functions by incorporating into the DNA of cancer cells, disrupting their growth and leading to cell death. Azacitidine is classified as a hypomethylating agent, which is used to treat certain blood disorders and cancers by altering the way cells grow.

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 immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression of the disease requires prompt medical attention to manage symptoms and complications.