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Study of Venetoclax and Azacitidine for Patients with Acute Myeloid Leukemia After Stem Cell Transplant

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 treatment combination involving two medications: Venetoclax and Azacitidine. Venetoclax, also known by its code name ABT-199, is taken as a film-coated tablet, while Azacitidine is administered as a powder for suspension for injection. The purpose of the study is to evaluate the safety and effectiveness of this treatment combination in patients who have undergone a procedure called allogeneic stem cell transplantation, which involves receiving healthy stem cells from a donor to help restore the bone marrow's ability to produce blood cells.

Participants in the study will be divided into two groups. One group will receive the combination of Venetoclax and Azacitidine, while the other group will receive the best supportive care, which means they will receive the standard care and treatments that are typically given to patients with AML. The study will monitor the participants over a period to see how well the treatment works in improving their overall survival and quality of life compared to the standard care. The study will also look at other factors, such as the time it takes for the disease to return and the participants' physical functioning and fatigue levels.

The trial is designed to determine the best dose of Venetoclax when used with Azacitidine and to see if this combination can help patients live longer and healthier lives after their stem cell transplant. The study will continue until 2026, and the results will help doctors understand if this treatment combination is a better option for patients with AML following a stem cell transplant.

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

    Beginning of the trial

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will receive detailed information about the medications involved, which include venetoclax and azacitidine.

    You will be asked to provide consent to participate in the trial, confirming your understanding and agreement to the procedures and treatments involved.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes confirming your diagnosis of acute myeloid leukemia (AML) and ensuring you have undergone an allogeneic stem cell transplantation within the past 60 days.

    Your health status will be evaluated, including blood tests to check your blast percentage in bone marrow and other necessary health parameters.

  3. Step 3

    Medication administration

    You will begin the treatment phase, which involves taking venetoclax as a film-coated tablet for oral use. The dosage and frequency will be determined by the study team based on your specific needs.

    In addition to venetoclax, you will receive azacitidine, which can be administered either intravenously (IV) or subcutaneously (SC). The study team will provide instructions on the administration method and schedule.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, your health will be closely monitored. Regular check-ups and tests will be conducted to assess your response to the treatment and to ensure your safety.

    You will be required to report any side effects or changes in your health to the study team promptly.

  5. Step 5

    Completion of the trial

    At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment and its impact on your health.

    You will receive information about the results of the trial and any follow-up care or treatment that may be necessary.

Who can join the trial?

11 criteria

  • Must be an adult male or female aged 18 years or older for Part 1, and at least 12 years old for Part 2.
  • The first dose of the study drug must be given between 28 to 100 days after a stem cell transplant.
  • No active infection with the virus that causes COVID-19.
  • Must have been diagnosed with Acute Myeloid Leukaemia (AML) and either planning for or have received a stem cell transplant within the last 60 days.
  • The percentage of cancer cells (blasts) in the bone marrow must be less than 10% before the transplant and less than 5% after the transplant.
  • Must have a bilirubin level (a substance made by the liver) that is less than 3 times the normal limit.
  • For Part 1: Must have an absolute neutrophil count (ANC) of at least 1,500 cells per microliter, measured twice at least 2 days apart. For Part 2: Must have an ANC of at least 1,000 cells per microliter, measured twice at least 2 days apart.
  • For Part 1: Must have a platelet count of at least 80,000 per microliter, measured twice at least 2 days apart. For Part 2: Must have a platelet count of at least 50,000 per microliter, measured twice at least 2 days apart.
  • Must have good kidney function, shown by a creatinine clearance greater than 30 mL/min.
  • For those 17 years and older, must have a Karnofsky Performance Scale (KPS) score greater than 50. For those aged 12 to 16, must have a Lansky Play-Performance Scale (LPPS) score greater than 40.
  • If a graft failure occurs during the registration period and another transplant is planned, the subject can be reconsented for the study.

Who cannot join the trial?

10 criteria

  • Patients who have not fully recovered from previous treatments or surgeries.
  • Patients with other active cancers that require treatment.
  • Patients with severe heart problems, such as a recent heart attack or heart failure.
  • Patients with uncontrolled infections.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to take oral medications.
  • Patients with a history of severe allergic reactions to similar drugs.
  • Patients who have received another investigational drug within a certain period before the study.
  • Patients with any condition that, in the opinion of the study doctor, makes participation unsafe.
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Investigated drugs

  • Venetoclax

    is a medication used in this clinical trial to help treat patients with Acute Myeloid Leukemia (AML). It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill the cancer cells and stop them from growing. In this trial, it is used in combination with another medication to see if it can improve the outcomes for patients who have undergone a stem cell transplant.

  • Azacitidine

    is another medication used in this trial alongside venetoclax. It is a type of chemotherapy that works by interfering with the growth of cancer cells. Azacitidine helps to stop the cancer cells from multiplying and can lead to their death. In this study, it is combined with venetoclax to see if the two medications together can be more effective in treating AML after a stem cell transplant.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML) after stem cell transplantation. It is used in combination with another medication, Azacitidine, to help improve survival rates in patients with AML. Venetoclax works by targeting and inhibiting a specific protein in cancer cells, which helps to trigger the death of these cells. It is classified as a BCL-2 inhibitor, which is a type of medication that interferes with the survival of cancer cells.

  • Azacitidine

    Azacitidine is administered via injection and is being evaluated in combination with Venetoclax for its role in treating Acute Myeloid Leukemia (AML) following stem cell transplantation. This medication is used to help improve the overall survival of patients with AML by working at the molecular level to interfere with the growth of cancer cells. Azacitidine is classified as a hypomethylating agent, which means it helps to modify the DNA of cancer cells, leading to their death.

Investigated diseases

Acute Myeloid Leukaemia – Acute Myeloid Leukaemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The disease progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they can spread to other parts of the body, including the liver, spleen, and lymph nodes. The progression of the disease can vary, with some individuals experiencing a rapid decline in health, while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507222-17-00Protocol codeM19-063Estimated enrolment424 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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