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Study of Venetoclax and Azacitidine for Maintenance Therapy in Patients with Acute Myeloid Leukemia in First Remission After 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), specifically in patients who are in their first remission after receiving standard chemotherapy. The study is investigating the use of two medications, Venetoclax and Azacitidine, as maintenance therapy. Maintenance therapy is a treatment given to help keep cancer from coming back after it has gone into remission. Venetoclax, also known by its code name ABT-199, is a medication that comes in the form of a film-coated tablet and is taken orally. Azacitidine is available in tablet form and can also be administered as a powder for suspension for injection, which means it can be given through a vein or under the skin.

The purpose of this study is to determine the best dose of Venetoclax in combination with Azacitidine for patients with AML who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after undergoing conventional induction and consolidation chemotherapy. The study will involve different parts, including dose confirmation and dose finding, to establish the recommended dose for these medications when used together as maintenance therapy. Participants will receive the study medications over a period of time, and their health will be monitored to assess the safety and effectiveness of the treatment.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study aims to provide valuable information on how well Venetoclax and Azacitidine work together in maintaining remission in patients with AML, potentially offering a new approach to managing this condition. The trial is expected to continue until 2025, with the goal of improving treatment options for patients with this type of leukemia.

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

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of venetoclax and azacitidine as maintenance therapy.

    The goal is to maintain remission in patients with acute myeloid leukemia after initial chemotherapy.

  2. Step 2

    Venetoclax administration

    Venetoclax is provided in the form of film-coated tablets.

    The tablets are taken orally. The specific dosage and frequency are determined based on the study's dose confirmation phase.

  3. Step 3

    Azacitidine administration

    Azacitidine is administered either intravenously or subcutaneously.

    The dosage is adjusted according to the study's requirements, with options of 200 mg or 300 mg tablets for oral use.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the effectiveness and safety of the treatment.

    The primary focus is on identifying any dose-limiting toxicities associated with the combination of venetoclax and azacitidine.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by April 20, 2025.

    Upon completion, the results will contribute to understanding the maintenance therapy's impact on acute myeloid leukemia in remission.

Who can join the trial?

12 criteria

  • The patient must be at least 18 years old.
  • The patient must have been newly diagnosed with **Acute Myeloid Leukemia (AML)**, which is a type of blood cancer.
  • The patient must have **intermediate or poor risk cytogenetics**, which refers to certain genetic characteristics of the leukemia cells.
  • The patient must have achieved **CR** (Complete Remission) or **CRi** (Complete Remission with incomplete blood count recovery) after finishing intensive chemotherapy treatments.
  • The patient should be within one of these time frames:
    • Achieved first CR or CRi within 120 days of starting the study treatment.
    • No more than 75 days since the last dose of intensive chemotherapy before joining the study.
    • The patient must have an **ECOG performance status** of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
    • The patient must meet certain laboratory test requirements:
      • **Creatinine clearance** of at least 30 mL/minute, which measures kidney function.
      • **Bilirubin** levels less than 3 times the upper limit of normal for Part 1, or less than 2 times for Part 3, indicating adequate liver function.
      • **Absolute neutrophil count** of at least 1,500 per microliter, which is a type of white blood cell important for fighting infections.
      • **Platelets** of at least 100,000 per microliter, which are cells that help with blood clotting.
      • Both male and female patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who have not achieved a complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after conventional induction and consolidation chemotherapy. Complete remission means that there are no signs of cancer in the body, and CRi means that there are no signs of cancer, but the blood counts are not fully normal.
  • Patients who are not in the age range specified for the study. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of patients.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are considered part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

  • Venetoclax

    is a medication used in this trial as a maintenance therapy for patients with Acute Myeloid Leukemia (AML) who are in their first remission after receiving conventional chemotherapy. It works by targeting and inhibiting a specific protein in cancer cells, which can help to prevent the cancer from returning.

  • Azacitidine

    is another medication used in combination with Venetoclax in this trial. It is also used as a maintenance therapy for patients with AML in remission. Azacitidine helps to stop the growth of cancer cells by interfering with their DNA, which can help to maintain remission and prevent the cancer from coming back.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally and is currently being studied in clinical trials as a maintenance therapy for patients with Acute Myeloid Leukemia (AML) in first remission. It is a targeted therapy that works by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor and is being evaluated for its effectiveness in prolonging remission in AML patients.

  • Azacitidine

    Azacitidine is administered either as an injection under the skin or intravenously. It is being investigated in clinical trials as a maintenance therapy for patients with Acute Myeloid Leukemia (AML) in first remission. Azacitidine works by incorporating into the DNA of cancer cells, disrupting their growth and leading to cell death. It is classified as a hypomethylating agent and is being studied for its potential to maintain remission in AML patients when used in combination with venetoclax.

Investigated diseases

Acute Myeloid Leukemia in First Remission – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. In the first remission stage, the disease has responded to initial treatment, and the number of leukemia cells has decreased significantly. During this phase, patients may not exhibit symptoms, and the disease is under control. However, the risk of relapse remains, and maintenance therapy is often considered to prolong remission. The progression of AML can vary, and ongoing monitoring is essential to detect any changes in the disease status.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507221-42-00Protocol codeM19-708Estimated enrolment122 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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