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Study of quizartinib‑based drug combination on measurable residual disease in adults 18‑60 with 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

The study focuses on younger adults diagnosed with Acute Myeloid Leukemia, a cancer that starts in the blood‑forming cells of the bone marrow. The purpose is to find out whether adding newer medicines to the standard chemotherapy can lower the amount of disease that remains after treatment, which is measured by MRD (measurable residual disease). MRD testing looks for very small numbers of cancer cells that cannot be seen with a regular microscope, helping doctors understand how well the treatment worked.

All participants receive the usual first‑line chemotherapy called 7+3 (seven days of one drug followed by three days of another). For patients whose leukemia carries a genetic change known as FLT3-ITD and does not have the CBF subtype, one group adds the oral drug quizartinib while another group uses midostaurin instead. For patients without the FLT3‑ITD change, the comparison is between a combination of the oral drug venetoclax with high‑dose cytarabine and high‑dose cytarabine alone. The response is checked after one cycle using either a DNA‑based test called PCR‑NGS (polymerase chain reaction with next‑generation sequencing) or a laboratory method called multiparameter flow cytometry, which can detect abnormal cells in a bone‑marrow sample.

After the first treatment cycle, doctors examine the bone marrow to see if MRD is negative. If cancer cells are still detected, additional cycles of chemotherapy are given, and the same tests are repeated. The study continues through the consolidation phase (extra treatment given after the initial response) to monitor overall survival and long‑term outcomes.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Begin Induction Chemotherapy

    You start the first treatment cycle, called Induction Chemotherapy. This phase is designed to achieve remission of acute myeloid leukemia.

  2. Step 2

    Daily Administration During Induction (Days 1‑7)

    Each day you receive an intravenous (IV) infusion of cytarabine at a dose of 3 g per square meter of body‑surface area (3 g/m²). The infusion is given once daily for seven consecutive days.

    For the first three days (Days 1‑3) you also receive an IV infusion of daunorubicin at 90 mg per square meter (90 mg/m²) each day.

    A daily IV infusion of dexamethasone phosphate 10 mg is given to help manage inflammation and reduce side effects.

    In addition, you take an oral study drug every day. Depending on the specific sub‑study you are assigned to, this will be either quizartinib 53 mg (two 26.5 mg tablets) or midostaurin 100 mg, taken by mouth each day throughout the induction phase.

  3. Step 3

    Monitoring and Supportive Care During Induction

    While you receive the infusions and oral medication, clinical staff monitor your vital signs, blood counts, and any side effects. Laboratory tests are performed regularly to ensure safety.

    You may be given additional supportive medicines, such as anti‑nausea drugs, to help you tolerate the treatment.

  4. Step 4

    Assessment of Measurable Residual Disease After Induction

    At the end of the seven‑day induction period, a bone‑marrow sample is taken to evaluate Measurable Residual Disease (MRD). This test determines whether leukemia cells are still detectable at a very low level.

  5. Step 5

    Decision Point: Proceed to Consolidation

    If the MRD assessment shows no detectable disease, you move on to the consolidation phase. If MRD is still present, the study protocol may adjust the next steps according to the specific sub‑study.

  6. Step 6

    Consolidation for Sub‑Study 1 (FLT3‑ITD Positive)

    You receive intermediate‑dose cytarabine (the same dose of 3 g/m²) administered by IV infusion on Days 1 through 5 of the consolidation cycle.

    During this consolidation cycle you continue the oral study drug that was started in induction: either quizartinib 53 mg daily for 14 days or midostaurin 100 mg daily for 14 days, as specified by your assigned treatment arm.

  7. Step 7

    Consolidation for Sub‑Study 2 (FLT3‑ITD Negative Salvage)

    You receive high‑dose cytarabine (HDAC) at 3 g/m² by IV infusion on Days 1, 3, and 5 of the consolidation cycle.

    In the same cycle you take the oral drug venetoclax at a dose of 400 mg per square meter (400 mg/m²) each day for 14 days, starting on Day 1.

  8. Step 8

    Consolidation for Sub‑Study 3 (MRD‑Guided Program)

    You receive subcutaneous (under the skin) injections of azacitidine at 75 mg/m² once daily for seven consecutive days.

    These injections are given as a suspension for injection, and the administration is performed by clinical staff in the clinic.

  9. Step 9

    Post‑Consolidation MRD Assessment

    After the consolidation cycle is completed, another bone‑marrow sample is taken to re‑evaluate Measurable Residual Disease (MRD). This determines the success of the consolidation therapy.

  10. Step 10

    Long‑Term Follow‑Up and Survival Monitoring

    You continue to attend scheduled clinic visits for routine blood tests, physical examinations, and additional MRD assessments as required by the study.

    Overall survival is recorded from the first day of consolidation therapy until death from any cause, as defined by the study endpoints.

Who can join the trial?

16 criteria

  • Be at least 18 years old but younger than 61 years.
  • Have health‑insurance coverage.
  • For the first sub‑study: have a genetic change called FLT3‑ITD (a mutation that makes leukemia cells grow faster) detected in the bone marrow, with a level that meets the study’s minimum requirement.
  • For the first sub‑study: be receiving the standard “7+3” induction chemotherapy (seven days of a drug called cytarabine plus three days of an anthracycline) as described in the trial plan.
  • For the first sub‑study: have normal blood levels of the minerals potassium, calcium (including corrected calcium if albumin is low), and magnesium.
  • For the second sub‑study: after one cycle of 7+3 chemotherapy, either have no response to treatment or have achieved a remission (called CR, CRh or CRi) but still show measurable disease by a test called multiparameter flow cytometry (MFC) at a level of 0.1% or higher in the bone marrow.
  • For the second sub‑study: be fit enough to receive a second cycle of intensive chemotherapy.
  • For the third sub‑study: after one cycle of 7+3 chemotherapy, have achieved a remission (CR/CRh/CRi) with no measurable disease by MFC (less than 0.1% or below the test’s detection limit) in the bone marrow.
  • Sign a written informed consent form agreeing to take part in the study.
  • Have newly diagnosed acute myeloid leukemia (AML) that is either “de novo” (newly appearing), secondary to a previously known blood disorder called myelodysplastic syndrome (MDS), or therapy‑related (developed after prior chemotherapy or radiation), as defined by the 2022 WHO classification.
  • Not have received any prior AML treatment except for hydroxyurea, and not have received prior MDS treatment except for blood‑forming growth factors.
  • Have an ECOG performance status of 3 or better (meaning you are able to care for yourself and are not bedridden).
  • Be eligible to receive induction chemotherapy (the initial intensive treatment for AML).
  • Have no heart problems that would prevent use of anthracycline drugs, such as uncontrolled heart failure, a recent heart attack, current signs of heart damage, uncontrolled irregular heartbeat, or a left‑ventricular ejection fraction (a measure of heart pumping ability) below 50%.
  • Have liver and kidney test results within acceptable ranges: total bilirubin no more than twice the upper normal limit, liver enzymes (AST/ASAT and ALT/ALAT) no more than 2.5 times the upper normal limit, and creatinine (a kidney function test) less than 150 µmol/L unless the values are caused by AML itself.
  • If you are a woman who could become pregnant, you must use an appropriate method of birth control during the study.

Who cannot join the trial?

29 criteria

  • Having a type of leukemia that started from a previously known blood disorder called a myeloproliferative neoplasm (MPN) (known as secondary AML).
  • Being pregnant or breastfeeding.
  • Having the specific AML subtype called CBF‑AML (relevant for sub‑study 1).
  • Having taken quizartinib or any other drug that blocks the FLT3 protein (called FLT3 inhibitors) before the study.
  • Having uncontrolled or serious heart problems, including any of the following:
    • Heart rate slower than 50 beats per minute (bradycardia).
    • A QTcF interval longer than 450 milliseconds (a measurement on an ECG that can raise the risk of dangerous heart rhythms).
    • A known or suspected long QT syndrome (a family or personal condition that makes the heart’s electrical system unstable).
    • Very high blood pressure (systolic ≥ 180 mm Hg or diastolic ≥ 110 mm Hg).
    • History of serious heart rhythm problems such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.
    • History of second‑degree (Mobitz II) or third‑degree heart block (patients with pacemakers are only eligible if they have never fainted or had serious rhythm problems while using the pacemaker).
    • History of uncontrolled chest pain (angina) or a heart attack (myocardial infarction) within the past six months.
    • Heart failure classified as New York Heart Association class 3 or 4 (moderate to severe difficulty with everyday activities).
    • Left ventricular ejection fraction ≤ 45 % (a measure of how well the main pumping chamber of the heart works).
    • Complete left bundle branch block (a specific pattern on an ECG that can affect heart function).
    • Having severe low levels of potassium, magnesium, or calcium (grade 3 or 4). Grade 3‑4 means the deficiency is marked and may need treatment.
    • Taking strong or moderate medicines that increase the activity of the liver enzyme CYP3A within two weeks (or five half‑lives) before randomization.
    • For sub‑study 2: Having AML with the FLT3‑ITD mutation but without CBF‑AML.
    • For sub‑study 2: Having an uncontrolled infection such as sepsis (body‑wide infection), multiple organ dysfunction syndrome, or a fever that does not improve with treatment.
    • For sub‑study 2: Having a proven uncontrolled fungal infection (positive blood test and cultures).
    • For sub‑study 2: Having taken venetoclax before the study.
    • Being legally unable to give consent because of guardianship, curatorship, or judicial protection.
    • For sub‑study 3: Having AML with the FLT3‑ITD mutation but without CBF‑AML.
    • Having acute promyelocytic leukemia (APL), identified by a specific chromosome change t(15;17) or by the presence of the PML::RARA gene fusion.
    • Having the chromosome change t(9;22) that creates the BCR::ABL1 gene (also called the Philadelphia chromosome) or a previous diagnosis of chronic myelogenous leukemia (CML).
    • Having a severe mental or brain disorder that is unrelated to AML and would make treatment unsafe, including the need for a bone‑marrow transplant from another person (allogeneic HSCT).
    • Any personal, family, social, or travel situation that would prevent regular follow‑up visits.
    • Having had another cancer that has not been stable (no progression) for at least two years, except for very early skin cancers or cancers that stay only in place (in‑situ carcinoma).
    • Having a severe infection that is not controlled at the time of study entry.
    • Having uncontrolled HIV‑1 or HIV‑2 infection, or an active hepatitis B or hepatitis C infection.
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Investigated drugs

  • Quizartinib

    is an oral medicine that blocks a specific protein (FLT3) that can make leukemia cells grow faster. In this trial it is added to the standard “7 + 3” induction chemotherapy to see if it improves the clearance of leukemia cells that are still detectable after treatment.

  • Dexamethasone

    is a steroid given by injection that helps reduce inflammation and can lessen side‑effects of chemotherapy. In this study it is used as background treatment to support patients during their chemotherapy cycles.

  • Daunorubicin

    is a chemotherapy drug given through a vein that attacks rapidly dividing cells, including leukemia cells. It is part of the standard “7 + 3” induction regimen used at the start of treatment in the trial.

  • Cytarabine

    is another chemotherapy medication given by injection that interferes with the DNA of cancer cells, helping to kill them. It is also a key component of the “7 + 3” induction therapy and is used at a higher dose (high‑dose cytarabine) in later parts of the trial.

  • Azacitidine

    is a medication injected under the skin that works by changing the way cancer cells read their genetic code, slowing their growth. It is tested in the trial as an additional drug that may help patients with acute myeloid leukemia.

  • Venetoclax

    is an oral drug that blocks a protein (BCL‑2) that helps leukemia cells survive. In the study it is combined with high‑dose cytarabine to see if this pairing clears more disease than high‑dose cytarabine alone.

What is already known about the treatment

  • Quizartinib

    This medication comes as a film‑coated tablet taken by mouth. It is an approved drug in several countries for treating acute myeloid leukemia that has a specific FLT3 mutation and has been studied extensively in medical research. It works by blocking the FLT3 protein, which stops the signals that tell leukemia cells to grow and survive. Quizartinib belongs to the class of FLT3 inhibitors, a type of targeted cancer therapy.

  • Dexamethasone Phosphate

    Given as an injectable solution that is infused into a vein. It is a long‑standing corticosteroid used worldwide and is included in many chemotherapy protocols. The drug mimics a natural hormone to lower immune activity and reduce inflammation, helping to control side effects of cancer treatment. It is classified as a corticosteroid and anti‑inflammatory agent.

  • Daunorubicin

    Administered by intravenous infusion of a clear solution. It is an approved anthracycline chemotherapy drug widely used for acute leukemia. Daunorubicin inserts itself into DNA, preventing cancer cells from copying their genetic material and leading to their death. It is classified as an anthracycline antibiotic and chemotherapy agent.

  • Cytarabine

    Delivered by intravenous injection of a sterile solution. It is a standard chemotherapy drug for acute leukemia and has a long history of use in clinical practice. The medication becomes a building block that interferes with DNA formation, stopping cancer cells from dividing properly. Cytarabine is an antimetabolite chemotherapy agent.

  • Azacitidine

    Provided as a powder that is mixed into a suspension and injected under the skin. It is approved for certain blood disorders, including some forms of acute leukemia, and is commonly used in treatment. Azacitidine adds a small chemical tag to DNA, which can turn on normal genes and slow the growth of cancer cells. It belongs to the class of hypomethylating agents, a type of epigenetic therapy.

  • Venetoclax

    Comes as a film‑coated tablet taken orally. It is approved for acute myeloid leukemia and chronic lymphocytic leukemia and has been studied in many clinical trials. The drug blocks a protein that helps cancer cells avoid death, allowing those cells to die naturally. Venetoclax is classified as a BCL‑2 inhibitor, a targeted cancer therapy.

Investigated diseases

  • Acute Myeloid Leukemia

    A cancer that starts in the bone marrow, where blood cells are made. It causes a rapid buildup of immature white blood cells that crowd out normal blood cells. These abnormal cells can spill into the bloodstream and travel to the spleen, liver, and other organs. The disease often worsens quickly as the marrow becomes increasingly filled with non‑functioning cells.

  • FLT3‑ITD Positive Acute Myeloid Leukemia

    A form of AML that carries an internal tandem duplication mutation in the FLT3 gene. This mutation sends strong growth signals to the leukemia cells, making them multiply faster than in other AML types. The rapid increase of abnormal cells leads to a quick rise in disease burden early in the course.

  • FLT3‑ITD Negative Acute Myeloid Leukemia

    AML that does not have the FLT3 internal tandem duplication mutation. The leukemia still involves uncontrolled growth of immature myeloid cells, but without the extra growth‑stimulating signal from the FLT3 mutation. The accumulation of abnormal cells progresses at a pace that can be slower than the FLT3‑ITD positive form.

  • Core Binding Factor Acute Myeloid Leukemia

    A subtype of AML defined by specific genetic rearrangements that affect core binding factor genes. These changes disrupt normal blood‑cell development, leading to a buildup of immature cells in the marrow. The disease spreads in a pattern that often involves the blood and can extend to other organs as the abnormal cells increase.

Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525759-96-00Protocol codeRC31/25-0438Estimated enrolment1 290 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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