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

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario Rio Hortega	Valladolid	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Principe De Asturias	Alcala De Henares	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hucfjxhq Uxjcqxfvhctln Mivlbrk De Vxpnechclu	Santander	Spain
Ihnxdrrn Cwzrkj Dggtyqnlzjrnbpdef	L'hospitalet De Llobregat	Spain
Hmfojujc Ufmxqzsbcwgkw Dkprgevu	Donostia / San Sebastian	Spain
Hihrreqh Ujwvaocdoymgo ds A Cypzoh	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	23.03.2026

Trial locations

Investigated drugs:

Quizartinib Dihydrochloride

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.

Investigated diseases:

Acute myeloid leukaemia

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.

Trial ID:

2025-522979-29-00

Protocol code:

VENP-A-QUI

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?