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Study of NMS-03592088 for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML)

Verified siteInvestigationalNo 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 the effects of a new treatment for two types of blood cancers: Acute Myeloid Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML). These conditions are characterized by the abnormal growth of blood cells, and the study is specifically targeting cases where the disease has returned after treatment or has not responded to previous therapies. The treatment being tested is a medication known by its code name, NMS-03592088, which is taken orally in the form of a hard capsule. This medication is designed to inhibit certain proteins, namely FLT3, KIT, and CSF1R, which are involved in the growth and survival of cancer cells.

The purpose of the study is to determine the most suitable dose of NMS-03592088 for patients and to explore its effectiveness in treating these blood cancers. Participants will take the medication daily for a set period, followed by a rest period, in cycles. The study will observe how the body tolerates the medication and its impact on the cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will be monitored closely to assess the medication's safety and any potential side effects. The trial aims to provide valuable information on whether NMS-03592088 can be a beneficial treatment option for patients with AML or CMML who have limited options due to the nature of their disease. This research is an important step in finding new ways to manage and treat these challenging conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the clinical trial, the patient will start taking the study medication, NMS-03592088. This medication is taken orally in the form of a hard capsule.

    The patient will follow one of two schedules: Schedule A involves taking the medication once daily for 21 consecutive days, followed by a 7-day rest period, making a complete cycle of 28 days. Schedule B involves taking the medication once daily for 28 consecutive days without a rest period.

  2. Step 2

    Monitoring and assessments

    Throughout the trial, the patient will attend scheduled visits for monitoring and assessments. These visits will include laboratory tests and other procedures to evaluate the patient's response to the treatment and monitor for any side effects.

    The patient must be willing and able to comply with these scheduled visits and procedures as part of the trial requirements.

  3. Step 3

    Use of contraception

    Patients participating in the trial must use highly effective contraception during the treatment period and for a specified time after discontinuation of the study treatment. This is to prevent any potential effects of the medication on pregnancy.

    Female patients must be surgically sterile, postmenopausal, or agree to use highly effective contraception. Male patients must be surgically sterile or agree to use highly effective contraception.

  4. Step 4

    Completion of treatment cycle

    At the end of each treatment cycle, the patient's response to the medication will be evaluated. This includes assessing the effectiveness of the treatment and any side effects experienced.

    The trial aims to determine the maximum tolerated dose and explore the antitumor activity of NMS-03592088 in patients with specific types of leukemia.

Who can join the trial?

13 criteria

  • Patients must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) that has come back or is not responding to treatment.
  • Patients must have tried standard treatments and either not responded or be unsuitable for them.
  • Patients must be adults, aged 18 years or older.
  • Patients must have a confirmed diagnosis of AML with a specific genetic mutation called FLT3-ITD.
  • Patients must be able to swallow capsules whole without chewing, crushing, or opening them.
  • Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
  • Patients must sign a consent form indicating they understand the nature of their disease, the study procedures, potential benefits, side effects, and alternative treatments.
  • Patients must use highly effective contraception. Female patients must be surgically sterile, postmenopausal, or agree to use highly effective contraception during treatment and for a specified period after. Male patients must be surgically sterile or agree to use highly effective contraception during treatment and for a specified period after.
  • Patients must have an ECOG performance status of 2 or less, which means they must be able to carry out all self-care but unable to carry out any work activities.
  • Patients must have had at least 2 weeks since their last cancer treatment before starting the study drug, except for a drug called hydroxyurea.
  • All side effects from previous treatments (except hair loss) must have improved to a mild level.
  • Patients must have adequate liver function, meaning certain liver enzymes and bilirubin levels must be within specified limits.
  • Patients must have adequate kidney function, meaning their serum creatinine and estimated glomerular filtration rate (eGFR) must be within specified limits.

Who cannot join the trial?

7 criteria

  • Patients who do not have Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) that has come back or is not responding to treatment.
  • Patients who have not tried all standard treatment options or for whom standard therapy is considered suitable.
  • Patients who are not adults.
  • Patients who are not willing to take the study medication as prescribed.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

NMS-03592088 is a medication being studied for its potential to help patients with certain types of blood cancers, specifically those who have not responded to other treatments or for whom standard treatments are not suitable. This medication works by targeting specific proteins in the body, known as FLT3, KIT, and CSF1R, which are involved in the growth and survival of cancer cells. By inhibiting these proteins, NMS-03592088 aims to stop or slow down the progression of the cancer. The study is exploring how well this medication can be tolerated by patients and its effectiveness in reducing cancer activity.

What is already known about the treatment

NMS-03592088 – This medication is taken orally and is being studied in clinical trials for its potential to treat certain types of blood cancers, specifically Acute Myeloid Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML) that have returned or are resistant to treatment. It is currently in the early stages of research, and scientists are working to determine the best dose and to see how well it works against these cancers. NMS-03592088 works by blocking specific proteins, FLT3, KIT, and CSF1R, which are involved in the growth and survival of cancer cells. It belongs to a class of drugs known as kinase inhibitors, which are designed to interfere with the signals that tell cancer cells to grow.

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 progression requires prompt medical attention to manage symptoms and complications.

  • Chronic Myelomonocytic Leukemia (CMML)

    Chronic Myelomonocytic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by an increased number of monocytes, a type of white blood cell, in the blood. The disease progresses slowly, with symptoms that may include fatigue, weight loss, and an enlarged spleen. Over time, CMML can lead to a decrease in the number of healthy blood cells, causing anemia, infections, and bleeding problems. The condition can transform into acute leukemia, which is more aggressive. Regular monitoring is essential to track the progression of the disease.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508655-39-00Protocol codeMKIA-088-001Estimated enrolment168 patientsSponsorNerviano Medical Sciences S.r.l.

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