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Study on Cobicistat, Venetoclax, and Azacitidine for Patients with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy

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 clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML). The study is investigating the effects of a combination of medications: cobicistat, venetoclax, and azacitidine. These medications are being tested together to see if they can help patients who have been newly diagnosed with AML and are not suitable for intensive chemotherapy treatments.

The purpose of the study is to understand how well this combination of medications works in improving the survival of patients with AML. The study will begin with a phase where the effects of adding cobicistat to venetoclax are observed. This is followed by a longer phase where the combination of cobicistat, venetoclax, and azacitidine is given to patients to assess its overall impact on their health. The study will last for a period of up to two years, during which patients will receive these medications and be monitored for their response to the treatment.

Participants in the study will receive the medications in different forms: azacitidine as a powder for injection, venetoclax as a film-coated tablet, and cobicistat as a tablet. The medications will be administered either orally or through injections, depending on the specific drug. The study aims to provide valuable insights into the potential benefits of this treatment combination for patients with AML who cannot undergo more aggressive chemotherapy options.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. Written informed consent is required to participate.

  2. Step 2

    Run-in phase

    The initial phase involves evaluating the pharmacokinetic equivalence of cobicistat-boosted venetoclax compared to unboosted venetoclax. This means assessing how the body absorbs, distributes, and eliminates the medication.

    During this phase, the patient will receive venetoclax and cobicistat orally. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Extension phase

    In this phase, the patient will receive a combination of azacitidine, venetoclax, and cobicistat. Azacitidine is administered subcutaneously or intravenously, while venetoclax and cobicistat are taken orally.

    The goal is to assess the practical applicability and therapeutic effect of this combination on overall survival in patients with acute myeloid leukemia (AML).

  4. Step 4

    Medication schedule

    Azacitidine is given through subcutaneous or intravenous routes. The specific dosage and schedule will be provided by the healthcare team.

    Venetoclax and cobicistat are taken orally. The dosage and frequency will be adjusted according to the study protocol.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient's response to the treatment and any side effects.

    These assessments may include blood tests, imaging studies, and other evaluations as deemed necessary by the healthcare team.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until December 31, 2027. Upon completion, the patient's overall health and response to the treatment will be reviewed.

    Further follow-up may be required to monitor long-term outcomes and any potential late effects of the treatment.

Who can join the trial?

10 criteria

  • Patients must have a diagnosis of **Acute Myeloid Leukaemia (AML)**, which is a type of blood cancer, according to a specific classification. This does not include a type called acute promyelocytic leukaemia.
  • Patients may have had previous treatment with **erythropoiesis stimulating agents (ESA)**, which are medicines that help the body make more red blood cells, for a previous condition called **myelodysplastic syndromes (MDS)**. These medicines must be stopped at least two weeks before joining the study.
  • Patients must be 18 years or older and considered not suitable for intensive chemotherapy, as judged by their doctor, or they must choose not to have intensive chemotherapy.
  • Patients must have a **WHO performance status** of 0, 1, or 2, which is a way to measure how well they can perform daily activities.
  • Patients must have adequate kidney and liver function, unless the disease affects these organs. This is shown by certain lab tests: a creatinine clearance of at least 30 mL/min, which measures kidney function, and specific levels of liver enzymes and bilirubin, which measure liver function.
  • Male patients who are sexually active must agree to use contraception from the first day of the study until at least 90 days after the last dose of the study drug. They must also agree not to donate sperm during this time.
  • Female patients must either be postmenopausal, meaning they are over 55 years old and have not had a menstrual period for at least 12 months without another medical reason, or they must agree to use adequate contraception during the study and until 180 days after the last treatment.
  • Patients must provide written informed consent, which means they understand the study and agree to participate.
  • Patients must be capable of giving informed consent, meaning they can understand the information about the study and make a decision to participate.
  • Patients must agree not to participate in another interventional study while receiving treatment in this study, unless approved by the study's main investigator.
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Investigated drugs

  • Venetoclax

    is a medication used in this trial to help treat acute myeloid leukemia (AML). It works by targeting and blocking a specific protein in cancer cells, which can help to stop the growth of these cells and lead to their death. In this study, venetoclax is being tested both with and without a booster to see how it affects the body and its effectiveness in treating AML.

  • Cobicistat

    is used in this trial as a booster for venetoclax. Its role is to enhance the effects of venetoclax by increasing its levels in the body, which may improve its ability to fight cancer cells. The study is examining how well cobicistat can boost venetoclax and whether this combination is more effective than using venetoclax alone.

  • Azacitidine

    is another medication included in this trial. It is used to treat AML by interfering with the growth of cancer cells, which can help to slow down or stop the progression of the disease. In this study, azacitidine is combined with venetoclax and cobicistat to see if this combination can improve treatment outcomes for patients who are not candidates for intensive chemotherapy.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally and is currently being studied in combination with cobicistat and azacitidine for treating acute myeloid leukemia (AML) in patients who are not candidates for intensive treatment. It is a BCL-2 inhibitor, which works by blocking the BCL-2 protein that helps cancer cells survive, leading to their death. Venetoclax is classified as an antineoplastic agent and is well-documented in medical literature for its role in treating certain types of leukemia.

  • Cobicistat

    Cobicistat is taken orally and is used in this trial to boost the effects of venetoclax in patients with acute myeloid leukemia (AML). It acts as a pharmacokinetic enhancer, increasing the concentration of venetoclax in the blood by inhibiting enzymes that break it down. Cobicistat itself does not have direct therapeutic effects on cancer but is classified as a cytochrome P450 inhibitor, primarily used to enhance the efficacy of other medications.

  • Azacitidine

    Azacitidine is administered via injection and is being tested in combination with venetoclax and cobicistat for treating acute myeloid leukemia (AML). It is a DNA methyltransferase inhibitor, which works by incorporating into DNA and RNA, leading to the reactivation of tumor suppressor genes and the death of cancer cells. Azacitidine is classified as an antineoplastic agent and is widely recognized in medical literature for its use in treating myelodysplastic syndromes and certain leukemias.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the bone marrow, where blood cells are made, and quickly moves into the blood. It affects a group of white blood cells called myeloid cells, which normally develop into various types of mature blood cells. In AML, these cells do not mature properly and multiply rapidly, leading to a buildup of abnormal cells that can crowd out healthy blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention to manage the overproduction of immature cells. AML is more common in adults and can vary in its specific characteristics and progression based on genetic factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505379-61-00Protocol codeHO171Estimated enrolment142 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

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