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Study of azacitidine combined with low-dose venetoclax treatment for patients with acute myeloid leukemia

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What is this trial about?

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

This clinical trial studies a treatment combination for patients with Acute Myeloid Leukemia, a type of blood cancer that affects the bone marrow and blood cells. The study examines the effectiveness of two medications used together: azacitidine, which is given as an injection under the skin, and venetoclax, which is taken by mouth.

The purpose of this research is to evaluate how well these two medications work together in treating patients with Acute Myeloid Leukemia. The treatment involves daily doses of venetoclax (up to 400 mg per day) combined with azacitidine (75 mg per square meter of body surface). The treatment period can last up to 24 months.

During the study, patients will receive regular medical examinations and blood tests to monitor their response to treatment and any side effects. The study will track how many patients respond to the treatment, how long the responses last, and how long patients survive after starting the treatment. The research team will also collect information about any health problems that occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment cycle
Your treatment will begin with a combination of two medications: azacitidine and venetoclax
Azacitidine will be administered through subcutaneous injection (an injection under the skin)
Venetoclax will be taken orally (by mouth) at a low dose intensity
Step 2
Monitoring phase
Your blood cell counts will be regularly monitored, particularly focusing on:
White blood cell count must remain below 25 x10E9/l
Regular checks of neutrophil levels (type of white blood cells) until they reach 0.5 x10E9/l
Monitoring of platelet count until it reaches 50 x10E9/l
Regular assessment of liver function through blood tests
Regular assessment of kidney function through blood tests
Step 3
Response evaluation
Your response to the treatment will be evaluated based on several factors:
Complete or partial remission of the disease
Duration of response to treatment
Overall health status and disease progression
Step 4
Side effect monitoring
Regular monitoring for potential side effects, including:
Blood-related effects such as low blood cell counts
Fever with low white blood cell count (febrile neutropenia)
Any other significant health changes
Step 5
Long-term follow-up
Your progress will be monitored throughout the study period until June 2026
Regular assessments of your overall survival and disease progression will be conducted
Continuous monitoring of your response to treatment

Who can join the trial?

9 criteria

Must be at least 18 years old
Must provide written consent to participate in the study and agree to additional research testing
Must have Acute Myeloid Leukemia (AML) that is either: - Newly diagnosed and not suitable for standard treatment - Has returned after previous treatment - Has not responded to previous treatments
Must have acceptable physical functioning status as measured by ECOG scale (a measure of daily living abilities): - Score of 2 or less if 75 years or older - Score of 3 or less if between 18-74 years old
Must have white blood cell count less than 25 x10E9/l
Must have adequate kidney function (creatinine clearance of 30 mL/min or higher)
Must have adequate liver function with: - Liver enzymes (ALT) no more than 4 times the normal limit - Bilirubin no more than 1.5 times the normal limit
For patients 70 years or older OR patients 18-69 years who cannot receive intensive chemotherapy, must meet at least one of these conditions: - Have significant heart, lung, or liver conditions - Have genetic features that make standard chemotherapy less effective - Have AML that developed after previous blood disorders - Choose not to receive intensive chemotherapy
For patients with returning AML, must be either: - 55 years or older with certain types of AML - 18 years or older and either unable to receive intensive chemotherapy or have had previous treatments including stem cell transplant

Who cannot join the trial?

14 criteria

Prior treatment with venetoclax (a medication used to treat blood cancers)
Active or uncontrolled central nervous system involvement from leukemia
Significant heart conditions including uncontrolled heart failure or unstable angina (chest pain)
Severe kidney problems (creatinine clearance less than 30 mL/min)
Active, uncontrolled infections requiring treatment
Other types of cancer requiring treatment within the last 2 years
Liver dysfunction (severe problems with liver function)
Pregnant or breastfeeding women
Known allergy or sensitivity to study medications
Participation in other clinical trials within 28 days before starting this study
Mental conditions that could interfere with following study procedures
Life expectancy less than 3 months due to other medical conditions
Unable to take oral medications
HIV, active hepatitis B, or hepatitis C infection

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Azacitidine
is a medication used to treat blood cancers. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the blood and bone marrow. It is commonly used in the treatment of acute myeloid leukemia (AML) and is given as an injection under the skin or through an intravenous line.
Venetoclax
is a targeted therapy medication that works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax helps trigger cancer cell death. It is taken as a tablet and is used to treat various blood cancers, including acute myeloid leukemia (AML).

What is already known about the treatment

Azacitidine
A chemotherapy medication administered through subcutaneous injection or intravenous infusion that belongs to the class of drugs called DNA methyltransferase inhibitors. It works by preventing the abnormal growth of cancer cells by interfering with DNA production, specifically targeting blood cancer cells in acute myeloid leukemia. This medication is widely used in clinical practice and has shown significant effectiveness in treating various blood disorders, particularly in patients who cannot tolerate more intensive chemotherapy regimens.
Venetoclax
An oral targeted therapy medication that functions as a selective BCL-2 inhibitor, which works by blocking a protein that helps cancer cells survive. It is administered in tablet form and has become an important treatment option for blood cancers, particularly in combination therapy for acute myeloid leukemia. The medication has demonstrated promising results in clinical trials, especially when used in combination with other anti-cancer drugs, and represents a significant advancement in targeted cancer therapy.

Investigated diseases

Acute Myeloid Leukemia - A type of blood and bone marrow cancer that affects the production of normal blood cells. It develops when young blood cells called myeloid cells begin to grow abnormally and accumulate in the bone marrow. These abnormal cells interfere with the production of normal blood cells, leading to a decrease in red blood cells, white blood cells, and platelets. The disease typically develops rapidly, causing symptoms such as fatigue, frequent infections, and easy bruising or bleeding. This condition can occur in both adults and children, though it's more common in older adults.