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Study on S65487 and Azacitidine for Adults with Untreated Acute Myeloid Leukemia Not Suitable for Intensive Treatment

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 testing a new treatment combination for adults who have not received previous treatment for AML and are not eligible for intensive treatment. The treatment being tested includes a new drug called S65487, which is a solution given through an infusion into the vein, combined with another medication called azacitidine, which is given as an injection under the skin. The purpose of the study is to evaluate the safety and effectiveness of this combination treatment.

The study is divided into two parts. In the first part, researchers will determine the safest dose of S65487 when used with azacitidine and observe any side effects. This part will help find the best dose to use in the second part of the study. In the second part, the focus will be on how well the treatment works in controlling the leukemia. Participants will receive the treatment and be monitored regularly to check their health and the response of the leukemia to the treatment.

Throughout the study, participants will have regular check-ups, including blood tests and other assessments, to ensure their safety and to measure how the treatment is affecting the leukemia. The study aims to provide valuable information on whether this new combination of S65487 and azacitidine can be a safe and effective option for treating Acute Myeloid Leukemia in patients who cannot undergo more intensive treatments.

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 study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures. Written consent is required before any study-specific procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes checking the participant's health status and medical history, focusing on conditions like heart or lung issues and overall performance status.

  3. Step 3

    Treatment phase I

    Participants will receive a combination of S65487 and azacitidine. S65487 is administered as a solution for infusion, while azacitidine is given as a subcutaneous injection. The goal is to determine the safety and appropriate dosage of these medications.

  4. Step 4

    Monitoring and adjustments

    Throughout the study, participants will be monitored for any side effects or adverse reactions. Adjustments to the dosage may be made based on these observations.

  5. Step 5

    Treatment phase II

    In this phase, the focus shifts to evaluating the effectiveness of the treatment. The same medications are used, and the response to treatment is closely monitored.

  6. Step 6

    Regular check-ups

    Participants will have regular check-ups, including blood tests and possibly bone marrow tests, to assess the treatment's impact on the leukemia.

  7. Step 7

    Completion of the study

    The study is expected to conclude by July 2025. Participants will have a final assessment to evaluate the overall outcomes of the treatment.

Who can join the trial?

7 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants must have a confirmed diagnosis of **Acute Myeloid Leukemia (AML)**, which is a type of blood cancer. This includes those who have not been treated before, or have AML that developed from a previous condition or due to certain treatments.
  • Participants should not be eligible for standard chemotherapy. This includes those who are 75 years or older, or those 18 years or older with certain health issues like significant heart or lung problems, or other conditions that make intensive chemotherapy unsuitable.
  • Participants 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, with lower numbers indicating better function.
  • Participants must provide written consent to join the study.
  • Participants must have proper kidney and liver function.
  • Participants must have a **White Blood Cell Count (WBC count)** of less than 25 billion per liter, which may be managed with certain treatments if necessary.

Who cannot join the trial?

10 criteria

  • Patients who have another type of cancer besides Acute Myeloid Leukemia (AML) cannot participate. Acute Myeloid Leukemia is a type of blood cancer.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with certain health conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
  • Patients who have allergies to the study medications or similar drugs may be excluded.
  • Patients who are participating in another clinical trial at the same time may not be eligible.
  • Patients with a history of certain heart conditions may be excluded.
  • Patients who have had a recent major surgery may not be eligible.
  • Patients with uncontrolled infections may be excluded from the study.
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Investigated drugs

  • S65487

    is a medication being studied for its potential to treat acute myeloid leukemia. It works by inhibiting a protein called Bcl2, which can help cancer cells survive. By blocking this protein, S65487 may help to kill cancer cells and stop the disease from progressing.

  • Azacitidine

    is a medication used in the treatment of certain types of blood cancers, including acute myeloid leukemia. It works by interfering with the growth of cancer cells, which can slow down or stop the progression of the disease. In this trial, azacitidine is combined with S65487 to evaluate their combined effect on the cancer.

What is already known about the treatment

S65487 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating acute myeloid leukemia (AML). It is a Bcl2 inhibitor, which means it works by blocking the Bcl2 protein that helps cancer cells survive, thereby promoting their death. S65487 is being evaluated for its safety, tolerability, and effectiveness when combined with azacitidine, particularly in patients who are not eligible for intensive treatment. It is still in the experimental phase, with ongoing research to determine the optimal dosage and therapeutic benefits.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia 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. AML is more common in adults and can vary in its specific genetic mutations, which can influence its behavior and progression. The disease requires medical attention to manage its symptoms and progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-510051-27-00Protocol codeCL1-65487-003Estimated enrolment52 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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