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A Study Comparing Two Treatment Schedules of Venetoclax and Azacitidine in Adults with Newly Diagnosed Acute Myeloid Leukemia Not Suitable for Intensive Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Acute Myeloid Leukemia, which is a type of blood cancer that affects the bone marrow and blood cells. The study is for people who cannot receive strong chemotherapy treatment because of their age or other health problems. The study will use two medications: venetoclax, which comes as tablets taken by mouth, and azacitidine, which is given as an injection under the skin, into a vein, or into a muscle. Some people in the study will also receive a placebo.

The purpose of this study is to compare two different ways of giving venetoclax together with azacitidine. One group of people will take venetoclax for only seven days during each treatment cycle, while the other group will take venetoclax continuously for the full cycle of twenty-eight days. Both groups will receive azacitidine. The study wants to find out if taking venetoclax for a shorter time works as well as taking it for the full cycle in terms of putting the leukemia into remission, which means reducing or eliminating the cancer cells. This will be measured by looking at whether people achieve complete remission or complete remission with incomplete recovery of the bone marrow during the first six treatment cycles.

During the study, people will receive their assigned treatment in repeated cycles. Each cycle lasts twenty-eight days, and people may continue treatment for multiple cycles depending on how well the treatment works and how well they tolerate it. The study will monitor how well the treatment controls the leukemia, how long people live, and what side effects occur. The study will also look at quality of life and how the different treatment schedules affect the need for blood transfusions, infections, and hospital stays. The total treatment period can last up to one hundred sixty-eight days for venetoclax and up to forty-two days for azacitidine.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment assignment
After joining the study, your treatment will be randomly assigned to one of two groups. This means that neither you nor your doctor will choose which treatment schedule you receive.
Both groups will receive the same medications: venetoclax (taken by mouth as tablets) and azacitidine (given as an injection under the skin, into a muscle, or into a vein).
The difference between the groups is how long you will take venetoclax during each treatment cycle. One group will take venetoclax for 7 days during each 28-day cycle, while the other group will take venetoclax continuously for 28 days during each cycle.
Step 2
Treatment cycles
Your treatment will be organized in cycles, with each cycle lasting 28 days.
During each cycle, you will receive azacitidine injections and venetoclax tablets.
The exact schedule for venetoclax will depend on which group you were assigned to: either 7 days or 28 days of treatment within each 28-day cycle.
You will continue these treatment cycles as long as the treatment is working and you are not experiencing unacceptable side effects.
Step 3
Medication administration
Venetoclax will be taken by mouth as film-coated tablets. The tablets are available in a strength of 100 mg.
Azacitidine will be administered as an injection. It comes as a powder that is mixed into a suspension for injection at a concentration of 25 mg per milliliter. The injection can be given under your skin, into a muscle, or into a vein, depending on what your doctor determines is best for you.
Your doctor will determine the specific doses and timing of these medications based on the treatment group you are assigned to and your individual response to treatment.
Step 4
Monitoring during the first 6 cycles
During the first 6 cycles of treatment, your response to the medications will be carefully monitored.
Your doctor will assess whether you achieve a complete remission, which means that leukemia cells are no longer detectable in your blood and bone marrow, or a complete remission with incomplete marrow recovery, which means that leukemia cells are gone but your blood cell counts have not fully returned to normal levels.
This monitoring period is important for evaluating how well the treatment is working for you.
Step 5
Bone marrow assessments
Throughout the study, you will need to undergo bone marrow aspiration procedures. This involves taking a sample of bone marrow, usually from your hip bone, to check for leukemia cells.
These procedures are necessary both for confirming your initial diagnosis and for monitoring your response to treatment during the study.
Your doctor will inform you when these procedures are scheduled.
Step 6
Quality of life assessments
During the study, you will be asked to complete questionnaires about your quality of life and general well-being.
These questionnaires are called EORTC QLQ-ELD14 and EuroQol EQ-5D-5L. They ask about your daily activities, symptoms, and overall health.
Your answers will help doctors understand how the treatment affects your day-to-day life.
Step 7
Safety monitoring
Throughout the study, your doctor will monitor you for any side effects or complications from the treatment.
This includes checking for febrile neutropenia (fever that occurs when your white blood cell count is low), infections, and the need for blood or platelet transfusions.
Your doctor will also monitor whether you need to be hospitalized and, if so, for how long.
Some treatment adjustments may be made if necessary, such as changes to your venetoclax dose or schedule, or delays in starting the next treatment cycle.
Step 8
Ongoing treatment
After the first 6 cycles, if the treatment is working and you are tolerating it well, you will continue with additional treatment cycles.
Each cycle will continue to last 28 days, and you will continue receiving both venetoclax and azacitidine according to your assigned treatment schedule.
Your doctor will continue to monitor your response to treatment and any side effects you may experience.
Step 9
Long-term follow-up
Your doctor will monitor your overall survival, which means tracking your health status over time.
Your doctor will also track event-free survival, which measures the time from the start of treatment until your leukemia worsens, you experience serious complications, or you pass away.
The duration of your response to treatment will be measured, meaning how long the treatment keeps your leukemia under control.
This follow-up will continue for the duration of the study.

Who can join the trial?

11 criteria

You must have a confirmed diagnosis of Acute Myeloid Leukemia, which is a type of blood cancer, based on specific medical guidelines, and you must not be able to receive standard intensive chemotherapy treatment because of your age or other health problems
You must be willing to sign and date a consent form that has been approved by an ethics committee before any study procedures begin
You must be able to receive treatment with Azacitidine and Venetoclax, which are the study medications, and you must agree to have bone marrow aspiration, which is a procedure where a small sample of bone marrow is taken with a needle for testing
You must be at least 60 years old
You must be expected to live for at least 12 weeks
You must be considered not suitable for intensive chemotherapy treatment, which means either you are 75 years old or older, or you are between 60 and 74 years old and have at least one of the following health conditions: a performance status score of 2 or 3 on the ECOG scale which measures how the disease affects your daily living abilities; a history of congestive heart failure which is when the heart does not pump blood well and requires treatment, or your heart pumping function is 50 percent or less, or you have ongoing chest pain; lung function tests showing 65 percent or less of expected capacity; kidney function with creatinine clearance which measures how well your kidneys filter waste between 30 and less than 45 units; moderate liver problems with bilirubin which is a substance that shows liver function more than 1.5 times but not more than 3 times the upper normal limit; or any other health problem that your doctor believes makes intensive chemotherapy unsuitable for you
You must have an ECOG Performance Status score, which measures your ability to perform daily activities, of 0 to 2 if you are 75 years or older, or 0 to 3 if you are between 60 and 74 years old
You must have adequate kidney function with a creatinine clearance of at least 30 units per minute, which will be calculated using a specific formula
You must have adequate liver function shown by blood tests for AST and ALT, which are liver enzymes, being no more than 3 times the upper normal limit, and bilirubin being no more than 1.5 times the upper normal limit, unless these abnormal results are caused by leukemia affecting your organs; if you are younger than 75 years, your bilirubin can be up to 3 times the upper normal limit
If you are female, you must be past menopause, meaning you have not had a menstrual period for at least 12 months with no other medical reason, or you must have had surgery to remove your ovaries, fallopian tubes, or uterus
If you are male and able to father children, you must use contraception with your partner starting before taking the study medication and continuing for 90 days after your last dose, and you must agree not to donate sperm during this same time period

Who cannot join the trial?

1 criterion

No exclusion criteria have been provided in the available study information

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Verified sites

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

Assistance Publique Hopitaux De Paris
Verified
Paris, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier De La Cote Basque
Verified
Bayonne, France

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Investigated drugs

Venetoclax
is a cancer medicine that works by helping cancer cells die. In this trial, it is being tested in two different ways: one group will take it for 7 days during each treatment cycle, while another group will take it continuously for 28 days during each treatment cycle.
Azacitidine
is a cancer medicine that helps stop cancer cells from growing and multiplying. All participants in this trial will receive this medication as part of their treatment for acute myeloid leukemia.

What is already known about the treatment

Venetoclax
Venetoclax is an oral medication taken by mouth in tablet form that is used to treat certain types of blood cancers, including acute myeloid leukemia. It works by blocking a specific protein called BCL-2 that helps cancer cells survive, which causes the cancer cells to die naturally. This medication belongs to a class of drugs known as BCL-2 inhibitors and is often combined with other cancer treatments like azacitidine to improve effectiveness in patients who cannot receive intensive chemotherapy.
Azacitidine
Azacitidine is a cancer medication given as an injection under the skin or into a vein that is used to treat blood disorders and certain types of leukemia, including acute myeloid leukemia. It works by helping to restore normal function to genes that control cell growth and development, which were turned off by the cancer, and by directly killing cancer cells. This drug is classified as a hypomethylating agent and is particularly useful for older patients or those who cannot tolerate more aggressive chemotherapy treatments.

Investigated diseases

Acute Myeloid Leukemia – Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow. It occurs when the bone marrow begins to make abnormal white blood cells called myeloblasts. These abnormal cells multiply rapidly and crowd out healthy blood cells. As the disease progresses, the number of normal blood cells decreases, which can lead to various complications. The condition develops quickly and requires prompt medical attention. Patients may experience symptoms such as fatigue, frequent infections, easy bruising, and bleeding due to the lack of healthy blood cells.