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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Region Oerebro Laen	Orebro	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Oulu University Hospital	Oulu	Finland
Lund University Hospital	Lund	Sweden
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Pirkanmaan hyvinvointialue	Tampere	Finland
Ukjnhkb Urxyfixlsx Hdjnejwq	Uppsala	Sweden
Hmjxv Brsmvj Hh	Bergen	Norway
Hezaumlj Uftjvpokdj Cufvhlg Howzuzkq	Helsinki	Finland
Avxpgn Udephlmdyr Hfnhwxzn	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	06.01.2022
Finland	Recruiting	06.01.2022
Norway	Recruiting	06.01.2022
Sweden	Recruiting	06.01.2022

Trial locations

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).

Investigated diseases:

Acute myeloid leukaemia

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.

Trial ID:

2023-510415-19-00

NCT ID:

NCT05431257

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?