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Study on Decitabine, Venetoclax, and Tretinoin for Patients with Acute Myeloid Leukemia Who Cannot Have Induction Chemotherapy

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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 trial is designed for patients who have been newly diagnosed with AML and are not eligible for standard induction chemotherapy, which is a common initial treatment for this disease. The study will explore the effects of a treatment combination that includes two medications, decitabine and venetoclax, along with either all-trans retinoic acid (ATRA) or a placebo. ATRA is a form of vitamin A that is sometimes used in cancer treatment.

The purpose of the study is to compare how well ATRA works compared to a placebo when added to the treatment with decitabine and venetoclax. Participants in the study will receive these treatments in the form of capsules taken by mouth. The study will last for a period of up to 60 days, during which the effects of the treatment on the patients' overall survival will be observed. The trial aims to provide valuable information on whether adding ATRA to the treatment can improve outcomes for patients with AML.

Throughout the study, researchers will monitor various aspects of the patients' health, including their response to the treatment and their quality of life. This will help determine the effectiveness of the treatment combination and its impact on the patients' well-being. The study is expected to continue until September 2027, providing a comprehensive evaluation of the treatment's potential benefits for individuals with acute myeloid leukemia.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose, procedures, and potential risks and benefits.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes checking your age, medical history, and current health status. Your white blood cell count will be measured, and other criteria will be evaluated to ensure you meet the trial requirements.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups. One group will receive the standard treatment with decitabine and venetoclax combined with all-trans retinoic acid (ATRA), while the other group will receive the standard treatment with a placebo.

  4. Step 4

    Treatment phase

    During the treatment phase, you will take the medications orally. Decitabine and venetoclax are part of the standard treatment. If you are in the ATRA group, you will also take all-trans retinoic acid. The exact dosage and frequency will be provided by the medical team, and you will be monitored regularly to assess your response to the treatment.

  5. Step 5

    Regular monitoring

    Throughout the trial, regular monitoring will occur. This includes blood tests, health assessments, and possibly other procedures to track your progress and any side effects. The goal is to ensure your safety and evaluate the treatment's effectiveness.

  6. Step 6

    End of treatment

    At the end of the treatment period, a final assessment will be conducted. This will involve evaluating your overall health, the effectiveness of the treatment, and any changes in your condition.

  7. Step 7

    Follow-up

    After completing the treatment, follow-up visits may be scheduled to continue monitoring your health and gather long-term data on the treatment's effects.

Who can join the trial?

13 criteria

  • Age must be 18 years or older.
  • Must have newly diagnosed acute myeloid leukemia (AML) and not have received any treatment for it before.
  • Must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 5 means dead.
  • White blood cell count must be less than 25 billion per liter. Medications like hydroxyurea or Ara-C can be used to meet this requirement.
  • Patients who are not expected to benefit from standard induction therapy or for whom standard induction chemotherapy is not feasible. This includes:
    • Age 75 years or older
    • ECOG performance status of 1 or more
    • HCT-CI score of 3 or more. This is a score that predicts the risk of complications after a stem cell transplant.
    • Adverse genetic factors
    • Patient declines standard aggressive chemotherapy
    • Lack of a social support system
    • Must have a projected life expectancy of at least 8 weeks.
    • Must provide written informed consent according to international guidelines and local laws. This means you agree to participate in the study after being informed about all aspects of the trial.
    • Must have the ability to understand the nature, significance, and consequences of the trial and the trial-related procedures and to comply with them.

Who cannot join the trial?

3 criteria

  • Patients who have not been newly diagnosed with acute myeloid leukemia (AML) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

  • Decitabine

    is a medication used in the treatment of certain types of blood cancers, including acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. In this trial, decitabine is part of the main treatment plan for patients who cannot undergo standard chemotherapy.

  • Venetoclax

    is another medication used to treat blood cancers like AML. It helps to kill cancer cells by targeting a specific protein that allows these cells to survive. By blocking this protein, venetoclax helps to reduce the number of cancer cells in the body. In this trial, it is used alongside decitabine as part of the main treatment.

  • All-trans retinoic acid (ATRA)

    is a form of vitamin A that is used in the treatment of certain types of leukemia. It helps cancer cells to mature and die more normally. In this trial, ATRA is being tested to see if adding it to the main treatment with decitabine and venetoclax can improve patient outcomes, specifically overall survival.

What is already known about the treatment

  • Decitabine

    Decitabine is administered as an injection into a vein, typically in a hospital or clinical setting. It is currently used in the treatment of certain blood cancers, including acute myeloid leukemia (AML), and is well-documented in medical literature. The main therapeutic indication for decitabine is to treat newly diagnosed AML in patients who cannot undergo standard chemotherapy. At the molecular level, decitabine works by incorporating into DNA and inhibiting an enzyme called DNA methyltransferase, which leads to the reactivation of genes that suppress tumor growth. It is classified as a hypomethylating agent in pharmacology.

  • Venetoclax

    Venetoclax is taken orally in the form of tablets, usually once a day with food. It is an established medication in the treatment of certain types of leukemia, including acute myeloid leukemia (AML), and is supported by extensive medical research. Venetoclax is primarily used to treat newly diagnosed AML in patients who are not candidates for intensive chemotherapy. Its mechanism of action involves targeting and inhibiting a protein called BCL-2, which helps cancer cells survive; by blocking this protein, venetoclax promotes the death of cancer cells. Venetoclax is classified as a BCL-2 inhibitor in pharmacological terms.

  • All-trans retinoic acid (ATRA)

    All-trans retinoic acid is administered orally in capsule form, typically as part of a combination therapy. It is being studied in clinical trials for its potential use in treating acute myeloid leukemia (AML), particularly in patients who are not eligible for standard chemotherapy. ATRA is used to enhance the effectiveness of other treatments by promoting the differentiation of immature blood cells into mature cells. At the molecular level, ATRA binds to retinoic acid receptors, which then regulate gene expression and promote cell differentiation. It is classified as a retinoid in pharmacology.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid growth of abnormal cells can lead to a decrease in red blood cells and platelets, further complicating the condition. AML requires prompt medical attention due to its fast progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507461-26-00Protocol codeP001516Estimated enrolment256 patientsSponsorMedical Center - University Of Freiburg

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