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Study on Adding Sulfasalazine, Idarubicin, and Cytarabine to Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia in Patients Aged 60 and Older

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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 the treatment of Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study is specifically for patients who are 60 years or older and have been newly diagnosed with a non-favorable form of AML. The treatment being tested involves adding Sulfasalazine to the standard chemotherapy regimen, which includes Idarubicin Hydrochloride and Cytarabine. Sulfasalazine is usually used to treat inflammatory conditions, but in this study, it is being tested for its potential benefits in treating AML.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment. The study will be conducted in two phases. In the first phase, the focus will be on determining the safest dose of the combination treatment that patients can tolerate. This involves monitoring for any side effects that might limit the dose patients can receive. In the second phase, the study will look at how well the treatment works in fighting leukemia, using historical data for comparison. The study will also involve monitoring patients' health through regular check-ups and tests to ensure their safety throughout the treatment process.

Participants in the study will receive the combination treatment over a period of time, with regular assessments to track their response to the treatment. The study aims to provide insights into whether adding Sulfasalazine to the standard chemotherapy regimen can improve outcomes for older patients with non-favorable AML. The trial will continue until the estimated end date in 2026, with the hope of finding a more effective treatment option for this challenging form of 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 study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and health status.

    Written consent is required before participation.

  2. Step 2

    Initial treatment phase

    The treatment involves a combination of medications: sulfasalazine, idarubicin hydrochloride, and cytarabine.

    Sulfasalazine is taken orally, while idarubicin hydrochloride and cytarabine are administered intravenously.

    The goal is to determine the safest and most effective dose of these medications.

  3. Step 3

    Dose escalation

    During this phase, the dose of the medications is gradually increased to identify the maximum dose that can be tolerated without severe side effects.

    Monitoring for any dose-limiting toxicities is crucial.

  4. Step 4

    Evaluation of treatment response

    The effectiveness of the treatment is assessed by measuring the response of the leukemia to the medication combination.

    This includes checking for complete remission and monitoring minimal residual disease (MRD) using specific criteria.

  5. Step 5

    Safety and side effects monitoring

    Throughout the study, safety is continuously monitored through regular tests and assessments.

    This includes checking heart function and laboratory values, as well as recording any adverse events.

  6. Step 6

    Pharmacokinetics and pharmacodynamics

    The study examines how the body processes the medications and their effects on the body.

    This helps to understand the interaction between the medications and their impact on leukemia cells.

  7. Step 7

    Final assessment

    At the end of the treatment cycle, a final assessment is conducted to evaluate the overall response to the treatment.

    This includes survival assessment at 12 months and other long-term outcomes.

Who can join the trial?

9 criteria

  • Patients must be **60 years or older**.
  • Must have **newly diagnosed Acute Myeloid Leukemia (AML)**. A short treatment with certain medications like hydroxyurea or steroids is allowed. Patients with AML that developed from previous blood disorders or due to past treatments are also eligible.
  • Must be considered suitable for **intensive chemotherapy** by the study doctor.
  • For Phase II, a special test called **Multiparameter Flow Cytometry (MFCM)** must be done at the start to help monitor the disease.
  • Must have an **ECOG performance status** of 2 or less. This is a scale that measures how well a patient can perform daily activities.
  • **Liver function tests** must be within certain limits, unless the changes are due to leukemia. This includes AST and ALT levels being no more than 3 times the normal limit, and bilirubin levels no more than 1.5 times the normal limit.
  • **Kidney function** must be good, with an estimated glomerular filtration rate (GFR) of at least 50 mL/min.
  • Must provide **written informed consent** before any study-related procedures begin.
  • Must be **eligible for National Health Insurance in France**.

Who cannot join the trial?

5 criteria

  • Patients who have not been recently diagnosed with non-favorable Acute Myeloid Leukemias cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who do not meet the clinical trial group requirements are not eligible.
  • Both male and female participants are considered, but those who do not fit the gender criteria are excluded.
  • Vulnerable populations, such as those who may not be able to give informed consent, are not included in the study.
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Investigated drugs

  • Sulfasalazine

    is a medication being tested in combination with other treatments for patients with a specific type of leukemia. It is usually used to treat inflammatory conditions, but in this trial, researchers are exploring its potential to help fight leukemia when used alongside other cancer treatments.

  • Idarubicin

    is a chemotherapy drug that is part of the standard treatment for certain types of leukemia. It works by interfering with the growth and spread of cancer cells in the body. In this trial, it is used in combination with other medications to see if it can improve treatment outcomes for patients.

  • Cytarabine

    is another chemotherapy medication commonly used to treat leukemia. It helps to kill cancer cells by preventing them from dividing and growing. In this study, it is combined with other drugs to evaluate its effectiveness in treating patients with newly diagnosed leukemia.

What is already known about the treatment

  • Sulfasalazine

    Sulfasalazine is administered orally and is being studied in combination with standard induction therapy for acute myeloid leukemia (AML) in patients aged 60 years or older. It is currently in clinical trials to determine its safety and effectiveness when used with other medications for this condition. The main therapeutic indication is for newly diagnosed non-favorable AML. Sulfasalazine works by reducing inflammation and modulating the immune system, although its exact mechanism in leukemia treatment is still under investigation. It is classified as an anti-inflammatory and immunomodulatory agent.

  • Idarubicin

    Idarubicin is administered intravenously and is a well-established medication used in the treatment of acute myeloid leukemia (AML). It is part of the standard induction therapy and is being studied in combination with other drugs to enhance its effectiveness. The main therapeutic indication is for newly diagnosed non-favorable AML. Idarubicin works by intercalating DNA strands, thereby inhibiting the replication of cancer cells. It is classified as an anthracycline antibiotic and antineoplastic agent.

  • Cytarabine

    Cytarabine is administered intravenously and is a key component of standard induction therapy for acute myeloid leukemia (AML). It is being evaluated in combination with other medications to improve treatment outcomes. The main therapeutic indication is for newly diagnosed non-favorable AML. Cytarabine works by interfering with DNA synthesis, which prevents the growth and division of cancer cells. It is classified as an antimetabolite and antineoplastic agent.

Investigated diseases

Acute Myeloid Leukemia – 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. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease progresses quickly and requires prompt medical attention. It is classified into different subtypes based on genetic and molecular features, which can influence the disease's behavior and response to treatment. AML is more common in adults and its incidence increases with age.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513084-38-00Protocol codeAPHP211176Estimated enrolment64 patientsSponsorAssistance Publique Hopitaux De Paris

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