Recruiting

A study comparing venetoclax, azacitidine, and quizartinib versus venetoclax and azacitidine in newly diagnosed acute myeloid leukemia patients not suitable for standard chemotherapy

Fast replyInvestigational

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 study involves patients with acute myeloid leukemia, which is a type of blood cancer that affects the bone marrow and blood cells. The study is examining treatment with a combination of medications including Quizartinib (also known by the code name AC220), Venetoclax, and Azacitidine. These medications are given to patients who have been newly diagnosed with this type of leukemia but are not suitable candidates for the usual intensive chemotherapy treatment, either because of their age or because they have other health conditions that make intensive treatment too risky. The study will compare two treatment approaches: one group will receive all three medications together, while the other group will receive only Venetoclax and Azacitidine without Quizartinib.

The purpose of this study is to determine whether adding Quizartinib to the standard combination of Venetoclax and Azacitidine improves survival rates compared to using just Venetoclax and Azacitidine alone. The medications are taken by mouth as tablets. During the study, patients will receive their assigned treatment combination in repeated cycles, and doctors will monitor how well the treatment works and how it affects the disease. The study will track various outcomes including how long patients live, how long they remain free from disease progression, whether the cancer responds to treatment, and how the treatment affects quality of life.

Throughout the study, doctors will perform regular tests to check the status of the leukemia and monitor for any side effects from the medications. Blood tests will be used to measure if there are any remaining cancer cells that cannot be seen under a regular microscope, which is checked using a method called next-generation sequencing. The study will also look at how often patients need blood or platelet transfusions and will gather information about healthcare resources used during treatment. Patients will be asked to complete questionnaires about their quality of life and daily functioning during the course of their treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment assignment
Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fair distribution of participants.
One group will receive a combination of three medications: venetoclax, azacitidine, and quizartinib.
The other group will receive a combination of two medications: venetoclax and azacitidine.
The assignment is random, meaning neither you nor your doctor can choose which group you will be in.
Step 2
Treatment with study medications
If assigned to the three-medication group, you will take venetoclax, azacitidine, and quizartinib.
If assigned to the two-medication group, you will take venetoclax and azacitidine.
Quizartinib is provided as a film-coated tablet that is taken by mouth.
The treatment will be given in cycles. Each cycle consists of a specific period of treatment followed by monitoring.
Your doctor will determine the exact dosage, frequency, and duration of each medication based on the study protocol and your individual response to treatment.
Step 3
Regular monitoring and assessments
Throughout the study, you will undergo regular medical assessments to monitor your condition and response to treatment.
These assessments will occur at specific time points: after 1 cycle, 4 cycles, and 9 cycles of treatment.
Your doctor will check for signs of disease response, including complete remission (when no disease can be detected) and other measures of treatment effectiveness.
Blood tests will be performed to check for measurable residual disease, which means very small amounts of disease that may remain even when standard tests show no disease.
You will also be monitored for any side effects or complications from the medications.
Step 4
Quality of life assessments
During the study, you will be asked to complete questionnaires about your quality of life and how you are feeling.
These questionnaires will ask about your physical health, emotional well-being, and daily activities.
The information you provide will help assess how the treatment affects your overall well-being.
Step 5
Transfusion monitoring
Your need for blood transfusions will be monitored throughout the study.
This includes tracking whether you require red blood cell transfusions or platelet transfusions, and how long you can go without needing these transfusions.
Achieving transfusion independence means you no longer need regular transfusions, which is a positive sign of treatment response.
Step 6
Long-term follow-up
After completing the active treatment phase, you will continue to be followed by your medical team.
This follow-up period allows monitoring of your long-term response to treatment and overall survival.
Your doctor will continue to assess whether the disease returns and how long the treatment effects last.
The study is expected to continue until December 2030.
Step 7
Contraception requirements during treatment
If you are a male participant who is sexually active, you must use contraception from the first day of treatment through at least 120 days after the last dose of study medication.
If you are a female participant of childbearing potential, you must use highly effective contraception from the time you sign the consent form through 7 months after the last dose of study medication.
Pregnancy tests will be performed to ensure you are not pregnant before starting treatment.
You must not breastfeed during the study.

Who can join the trial?

8 criteria

You must have a confirmed diagnosis of acute myeloid leukemia, which is a type of blood cancer, that has not been treated before
You must not be able to receive standard intensive chemotherapy, which is a strong cancer treatment, because of your age or other health problems
You must be at least 75 years old, or be between 18 and 75 years old with at least one of the following health conditions: having an ECOG Performance Status of 2 or 3, which is a score that measures how the disease affects your daily activities; having a history of heart failure that needed treatment, which means your heart does not pump blood as well as it should, or having a heart pumping strength between 45% and 55%, or having stable chest pain; having lung function tests showing 65% or less of expected values or having long-term lung disease; having kidney function between 30 and 50 milliliters per minute, which means your kidneys are not working at full strength; having liver problems with blood test results 1.5 to 3 times higher than normal; having a previous cancer that is not active or controlled; having any other health problem that your doctor believes makes intensive chemotherapy unsafe
If you are over 75 years old, your ECOG Performance Status must be 2 or less. If you are between 60 and 75 years old, your ECOG Performance Status must be 3 or less
If you are a man who is sexually active, you must agree to use birth control methods from the first day of the study until at least 120 days after your last dose of study medication
If you are a woman, you must be past menopause, which means you have not had periods for at least 1 year, or have had surgery to remove your ovaries, fallopian tubes, or uterus, or if you can become pregnant, you must agree to use two effective birth control methods at the same time from signing the consent form until 7 months after your last dose of study medication, or agree to not have sexual intercourse during this time
If you are a woman who can become pregnant, you must have a negative pregnancy test and must not be breastfeeding
You must voluntarily sign and date a consent form before any study procedures begin, understanding that you can withdraw from the study at any time

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria listed, it is not possible to identify specific medical conditions, treatments, or situations that would prevent participation
Typically, exclusion criteria might include things like other serious illnesses, certain medications being taken, pregnancy, or previous treatments, but none are specified in the provided information

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

Verified
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas De Gran Canaria, Spain
Responsive
Hospital Universitario De Jaen
Jaen, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

Where you can join this trial

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

RecruitingNot yet 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 medicine used to treat blood cancers. It works by helping cancer cells die naturally. In this trial, it is being tested in combination with other medications to treat acute myeloid leukemia in patients who cannot receive standard chemotherapy.
Azacitidine
is a cancer medicine that helps stop cancer cells from growing. It is used to treat blood cancers and works by affecting how cancer cells develop. In this trial, it is being combined with other medications to treat newly diagnosed acute myeloid leukemia.
Quizartinib
is a targeted therapy medicine that blocks specific proteins that help cancer cells grow. It is being tested in this trial as part of a three-drug combination to see if adding it to the standard treatment improves outcomes for patients with acute myeloid leukemia who cannot receive intensive chemotherapy.

Quizartinib Dihydrochloride

What is already known about the treatment

Venetoclax
Venetoclax is a medication that comes in tablet form and is taken by mouth, usually once daily with food and water. It is an approved cancer treatment that works by blocking a protein called BCL-2, which helps cancer cells survive, thereby allowing the abnormal cells to die naturally. This drug belongs to a class of medicines known as BCL-2 inhibitors and is primarily used to treat certain blood cancers, including acute myeloid leukemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma. In this clinical trial, it is being studied in combination with other medications to determine if the combination therapy improves survival rates in patients with newly diagnosed acute myeloid leukemia who cannot receive standard intensive chemotherapy.
Azacitidine
Azacitidine is a cancer medication that is given either as an injection under the skin or into a vein, typically administered in cycles over several days each month. It is an established treatment in blood cancer therapy that works by interfering with the growth of cancer cells and helping bone marrow produce normal blood cells by blocking certain enzymes that affect DNA and gene expression. This medication is classified as a hypomethylating agent and is used to treat various types of myelodysplastic syndromes and acute myeloid leukemia. In this study, it is being combined with venetoclax and quizartinib to evaluate whether this three-drug combination is more effective than the standard two-drug combination for patients with newly diagnosed acute myeloid leukemia who are not suitable candidates for intensive chemotherapy.
Quizartinib
Quizartinib is an oral medication taken in tablet form, usually once daily, and is being investigated as a targeted therapy for certain types of acute myeloid leukemia. It works by blocking a specific protein called FLT3, which is often abnormally active in some leukemia cells and promotes their uncontrolled growth and survival. This drug belongs to a class of medications known as FLT3 inhibitors or tyrosine kinase inhibitors and is particularly relevant for patients whose leukemia cells have mutations in the FLT3 gene. In this clinical trial, quizartinib is being tested in combination with venetoclax and azacitidine to determine if adding it to the standard two-drug regimen improves outcomes for newly diagnosed acute myeloid leukemia patients who cannot tolerate standard intensive chemotherapy.

Investigated diseases

Acute Myeloid Leukemia – Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow. The disease begins in the bone marrow where abnormal white blood cells develop and multiply rapidly. These abnormal cells crowd out healthy blood cells and prevent them from functioning properly. As the disease progresses, the abnormal cells accumulate in the bone marrow and spill into the bloodstream. The condition develops quickly and can spread to other parts of the body including the liver, spleen, and lymph nodes. Without intervention, the number of healthy blood cells continues to decrease, leading to symptoms such as fatigue, frequent infections, and easy bleeding or bruising.