RecruitingRare disease

Study comparing venetoclax with intensive chemotherapy (daunorubicin, cytarabine, gemtuzumab ozogamicin) in patients with favorable risk acute myeloid leukemia

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients with Acute Myeloid Leukaemia, a type of blood cancer that affects the bone marrow and blood cells. The study aims to compare two different treatment approaches for this disease. One approach uses venetoclax (also known as ABT-199) combined with low-dose cytarabine, while the other approach uses intensive chemotherapy that includes daunorubicin hydrochloride and gemtuzumab ozogamicin.

The first treatment option involves taking venetoclax tablets by mouth along with cytarabine given through injections or infusions. The second treatment option consists of intensive chemotherapy medications given through intravenous infusions. The study will monitor how well each treatment works in preventing the return of the disease and helping patients achieve remission, which means there are no detectable cancer cells.

During the study, patients will receive treatment for up to 24 months. Throughout this time, doctors will regularly check the patient's health status, perform blood tests, and monitor for any side effects. The study will track how long patients remain free from disease progression and measure their overall survival time. Quality of life and general health status will also be assessed at various points during the study 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 assignment
After joining the study, you will be assigned to receive either venetoclax with low-dose cytarabine or intensive chemotherapy
Your treatment assignment will be based on your specific molecular profile
Step 2
Treatment cycles
You will receive two cycles of the assigned treatment
The medications may include:
- Venetoclax: tablets taken by mouth
- Cytarabine: given through an IV (intravenous) line or as an injection under the skin
- Daunorubicin: given through an IV line
- Gemtuzumab ozogamicin: given through an IV line
Step 3
Response evaluation
After two treatment cycles, your response to therapy will be evaluated
This evaluation includes checking if the leukemia cells have decreased or disappeared from your blood and bone marrow
Step 4
Follow-up assessments
Regular check-ups will occur at months 3, 6, 12, 18, and 24
These visits will include:
- Blood tests to monitor your condition
- Assessment of your general health and ability to perform daily activities
- Quality of life evaluations
At months 12 and 24, a comprehensive health assessment for older adults will be performed
Step 5
Monitoring period
Your health status will be monitored for up to 24 months
The study will track:
- How well the treatment is working
- Any side effects you may experience
- Your overall survival and quality of life
- The amount of hospital care and medical support you need

Who can join the trial?

8 criteria

Must be diagnosed with CD33 positive Acute Myeloid Leukaemia (a type of blood cancer)
Must be 55 years or older
Must have specific genetic markers: NPM1 mutation and be negative for FLT3 ITD (patients with FLT3 TKD mutation can participate)
Must have an ECOG performance status of 0-2 (a scale measuring daily living abilities, where 0 means fully active and 2 means able to do light activities)
Must have kidney function tests showing serum creatinine no more than 1.5 times the normal upper limit
Must have liver function tests (ALT and AST) no more than 2.5 times the normal upper limit, and bilirubin no more than 2 times the normal upper limit
Must be able to provide written informed consent
Must be considered physically fit enough to receive intensive chemotherapy with anthracyclines (strong cancer medications) as determined by their doctor

Who cannot join the trial?

15 criteria

Prior chemotherapy or targeted therapy for Acute Myeloid Leukaemia (AML) except for emergency treatment
Active central nervous system involvement with AML (cancer cells present in brain or spinal cord)
Severe heart conditions including:
- Uncontrolled heart failure
- Recent heart attack (within last 6 months)
- Unstable heart rhythm problems
- Severe liver problems (liver function tests more than 3 times above normal limits)
- Severe kidney problems (requiring dialysis)
- Active uncontrolled infections
- Other types of cancer requiring treatment
- Pregnancy or breastfeeding
- Unable to take oral medications
- Known allergies to study medications
- Mental conditions that would interfere with study compliance
- Life expectancy less than 3 months due to other medical conditions
- Participation in other clinical trials within last 30 days

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Verified sites

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Aarhus University Hospital
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Aarhus, Denmark

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Investigated drugs

Venetoclax
is a medication used to treat acute myeloid leukemia (AML). It works by blocking a protein that helps cancer cells survive. This medication is taken orally and helps to kill cancer cells while sparing healthy cells.
Cytarabine
is a chemotherapy medication used to treat blood cancers, including acute myeloid leukemia. It works by interfering with DNA synthesis in cancer cells, which prevents them from growing and dividing. This medication is typically given through an intravenous infusion.
Intensive Chemotherapy
refers to a strong combination of cancer-fighting medications given at high doses to treat acute myeloid leukemia. This treatment approach is typically administered in a hospital setting and may require extended hospital stays due to its intensity and side effects.

What is already known about the treatment

Venetoclax
An oral targeted therapy medication used in the treatment of Acute Myeloid Leukemia (AML), particularly in cases with favorable risk profiles. This medication works by blocking the BCL-2 protein, which helps cancer cells survive, leading to their programmed cell death (apoptosis). Venetoclax is typically administered in combination with low-dose cytarabine and represents a less intensive treatment option compared to traditional chemotherapy, making it particularly suitable for certain patient populations. The drug belongs to the class of BCL-2 inhibitors and has shown promising results in clinical trials for AML treatment, offering a more targeted approach to leukemia therapy.
Cytarabine
A chemotherapy medication administered intravenously or subcutaneously, used in the treatment of various types of leukemia, including Acute Myeloid Leukemia (AML). This drug works by interfering with DNA synthesis in rapidly dividing cells, preventing cancer cells from multiplying and spreading. Cytarabine belongs to the antimetabolite class of chemotherapy drugs and can be used in different doses, with low-dose applications being particularly relevant in combination therapy with newer targeted agents like venetoclax. The medication has been a cornerstone of AML treatment for many years and continues to play a crucial role in modern treatment protocols.

Investigated diseases

Acute Myeloid Leukemia - A type of blood and bone marrow cancer that progresses rapidly. The disease begins in the bone marrow, where abnormal white blood cells multiply uncontrollably, interfering with the production of normal blood cells. These abnormal cells build up in the bone marrow and blood, reducing the body's ability to produce healthy blood cells. The condition typically develops quickly, over days or weeks, affecting the production of red blood cells, platelets, and normal white blood cells. It most commonly occurs in older adults, though it can affect people of any age.