Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of venetoclax with fludarabine, cytarabine and idarubicin combination therapy in newly diagnosed patients with intermediate or high-risk Acute Myeloid Leukemia

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Leukemia, a type of blood cancer that affects bone marrow cells. The research evaluates a treatment combination that includes Venetoclax (taken as tablets) along with three chemotherapy medications: Fludarabine, Cytarabine, and Idarubicin (given through intravenous infusion). This combination is being tested in people who are newly diagnosed with the disease and have an intermediate or high risk of the disease returning.

The purpose of this research is to determine if adding Venetoclax to standard chemotherapy is safe and effective in eliminating the disease from the body. The study will investigate how well patients respond to this combination treatment and monitor any side effects that may occur.

During the study, participants will receive the combination of medications as their initial treatment for Acute Myeloid Leukemia. The treatment involves taking Venetoclax tablets daily along with receiving the other medications through an intravenous line. Doctors will regularly monitor participants' health status and assess how well the treatment is working through various medical examinations and blood tests.

The research process

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

  1. Step 1

    Initial treatment phase

    You will receive a combination of medications through different methods:

    - Venetoclax tablets taken by mouth (available in 10mg, 50mg, and 100mg doses)

    - Fludarabine given through an intravenous (IV) line

    - Cytarabine given through an intravenous (IV) line

    - Idarubicin given through an intravenous (IV) line

  2. Step 2

    Treatment monitoring

    Regular checks will be performed to monitor:

    - Blood tests to measure liver function

    - Kidney function tests

    - Physical examinations

    - Heart monitoring through ECG tests

    - Quality of life assessments

  3. Step 3

    Response evaluation

    Your response to treatment will be evaluated after the first or second course of therapy

    The goal is to achieve complete remission (absence of disease signs)

  4. Step 4

    Safety monitoring

    Throughout the treatment, you will be monitored for:

    - Any side effects from the medications

    - Signs of tumor lysis syndrome (a condition that can occur when cancer cells are destroyed quickly)

    - Changes in blood test results

    This monitoring will continue for up to one year

  5. Step 5

    Study completion

    The study is expected to continue until July 31, 2025

    Your participation duration will depend on your individual treatment plan and response

Who can join the trial?

15 criteria

  • Must be diagnosed with Acute Myeloid Leukemia (a type of blood cancer), newly diagnosed and confirmed by WHO 2017 criteria
  • Age between 18 and 65 years
  • Must be physically fit enough to receive chemotherapy, as determined by the doctor
  • Must have intermediate or high-risk disease according to ELN criteria (European LeukemiaNet risk classification)
  • Must have good physical functioning status (ECOG Performance Status of 2 or better - able to care for self but unable to work)
  • Life expectancy must be greater than 12 weeks
  • Must have adequate liver function, including:
    • Normal or slightly elevated bilirubin levels
    • Liver enzymes (ALT and AST) within acceptable limits
    • Must have adequate kidney function (creatinine clearance of 50 ml/min or better)
    • Must have normal or near-normal pancreas function (lipase and amylase levels)
    • For women who can become pregnant:
      • Must have a negative pregnancy test within 72 hours before starting treatment
      • Must use effective birth control during treatment and for 100 days after
      • For men: Must use effective birth control or be surgically sterile
      • Must be able to understand and sign informed consent documents
      • Any previous side effects from treatments must be resolved or mild before starting therapy

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Patients with low-risk Acute Myeloid Leukemia according to ELN classification (a standardized risk assessment system)
  • Previous treatment with Venetoclax (a type of cancer medication)
  • Active or uncontrolled infections
  • Severe heart conditions or uncontrolled heart disease
  • Severe liver dysfunction
  • Severe kidney dysfunction
  • Known allergy or hypersensitivity to study medications
  • Pregnant or breastfeeding women
  • Unable to provide informed consent
  • Participation in another clinical trial within the last 30 days
  • Active second cancer requiring treatment
  • Mental conditions that could interfere with study compliance
  • History of non-compliance with medical treatments
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Venetoclax - This medication works by blocking a protein that helps cancer cells survive. In this trial, it is being tested as an add-on treatment for acute myeloid leukemia (AML) in newly diagnosed patients. Fludarabine - This is a chemotherapy medication that works by interfering with cancer cell DNA, helping to stop cancer cells from growing and dividing. Cytarabine - This chemotherapy medication works by preventing cancer cells from making and repairing DNA, which helps stop cancer growth and spread. Idarubicin - This is a type of chemotherapy medication that works by damaging the DNA of cancer cells, preventing them from multiplying. It belongs to a group of drugs called anthracyclines. These medications are being tested together as a combination therapy for patients who have just been diagnosed with acute myeloid leukemia (excluding the M3 subtype).

What is already known about the treatment

  • Venetoclax

    An oral medication used in the treatment of Acute Myeloid Leukemia (AML), administered in tablet form as part of combination therapy with chemotherapy drugs. It belongs to the class of BCL-2 inhibitors, working by blocking the BCL-2 protein that helps cancer cells survive, thus promoting cancer cell death. This targeted therapy has shown promising results in clinical trials for newly diagnosed AML patients, particularly when combined with standard chemotherapy regimens like fludarabine, cytarabine, and idarubicin (FLAI scheme).

  • Fludarabine

    An intravenously administered chemotherapy medication used in combination therapy for Acute Myeloid Leukemia. It belongs to the class of purine analogs and works by interfering with DNA synthesis in cancer cells, preventing their multiplication and growth. The drug is commonly used as part of intensive chemotherapy regimens and has demonstrated effectiveness when combined with other anti-cancer medications.

  • Cytarabine

    A chemotherapy medication administered intravenously as part of combination therapy for Acute Myeloid Leukemia. It belongs to the antimetabolite class of drugs and works by interfering with DNA synthesis during cell division, particularly targeting rapidly dividing cancer cells. This medication is a cornerstone of AML treatment protocols and is frequently used in combination with other chemotherapy agents.

  • Idarubicin

    An intravenous chemotherapy medication from the anthracycline class, commonly used in treating Acute Myeloid Leukemia. It works by inserting itself into DNA strands and blocking the enzyme topoisomerase II, preventing cancer cells from dividing and multiplying. This powerful chemotherapy agent is typically administered as part of combination therapy protocols and has shown significant effectiveness in treating newly diagnosed AML.

Investigated diseases

Acute Myeloid Leukemia - A type of blood and bone marrow cancer that affects the production of blood cells. It begins in the bone marrow where blood cells are made, causing rapid growth of abnormal white blood cells that interfere with normal blood cell production. These abnormal cells build up in the bone marrow and blood, leaving less room for healthy blood cells. The disease develops quickly, typically over days or weeks, affecting the body's ability to fight infections and maintain normal blood functions. As the leukemia cells increase, they can spread to other parts of the body, including the lymph nodes, liver, spleen, central nervous system, and testicles.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-510517-26-00Protocol codeAML1718Estimated enrolment124 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.