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Study of L-Annamycin and Cytarabine for Adults with Refractory or Relapsed Acute Myeloid Leukemia

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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 approach for adults whose AML has returned or did not respond to initial treatment. The treatment being studied involves a combination of two drugs: Liposomal Annamycin and Cytarabine. Liposomal Annamycin is a form of chemotherapy that is designed to target cancer cells more effectively, while Cytarabine is a well-known chemotherapy drug used to treat AML. The study will compare this combination to a placebo combined with Cytarabine to see which is more effective as a second-line treatment.

The purpose of the study is to find the best dose of Liposomal Annamycin when used with Cytarabine and to confirm if this combination works better than the placebo with Cytarabine. Participants will receive the treatment through an infusion, which means the medication is given directly into the bloodstream. The study is divided into two parts. In the first part, researchers will determine the optimal dose of Liposomal Annamycin. In the second part, they will test this dose against the placebo to see if it improves the rate of complete remission, which means the cancer is no longer detectable after one cycle of treatment.

Participants will be monitored closely throughout the study to assess the safety and tolerability of the treatment. The study will also look at how long the remission lasts, overall survival rates, and the possibility of undergoing a bone marrow transplant after achieving remission. The trial aims to provide valuable information that could lead to better treatment options for people with refractory or relapsed AML.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of L-Annamycin and cytarabine, while the other group will receive a placebo with cytarabine. This process is double-blind, meaning neither you nor the study team will know which group you are in.

  2. Step 2

    Treatment cycle

    The treatment cycle lasts for 35 days, with a possible variation of 14 days. During this time, you will receive the assigned treatment.

    If you are in the group receiving L-Annamycin, the dosage will be determined based on the results from Part A of the study. The dosage options are either 190 mg/m²/day or 230 mg/m²/day. Cytarabine will be administered at a dosage of 2.0 g/m²/day.

    The medications are given through an infusion, which means they are delivered directly into your bloodstream through a vein.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment cycle, you will undergo regular monitoring and assessments to evaluate your response to the treatment. This includes checking for any side effects and measuring the rate of complete remission, which is the absence of detectable cancer cells in your body.

    Additional assessments may include blood tests and other necessary evaluations to ensure your safety and the effectiveness of the treatment.

  4. Step 4

    End of treatment cycle

    At the end of the treatment cycle, the study team will analyze the results to determine the effectiveness of the treatment. This includes measuring the rate of complete remission and other outcomes such as the duration of remission and overall survival.

    The study will also assess the safety and tolerability of the treatment to ensure it is safe for participants.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) according to the latest guidelines.
  • Must have refractory/relapsed AML, meaning the disease has returned or did not respond after one previous treatment.
  • Must be between 18 and 80 years old.
  • Must not have received chemotherapy, radiation, or major surgery within 2 weeks before starting the study treatment, unless fully recovered from any side effects. Certain treatments to control white blood cell count and infections are allowed.
  • Must not have participated in another clinical trial within 4 weeks before starting the study treatment.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how the disease affects daily living abilities.
  • Must have a life expectancy of more than six weeks.
  • Must have adequate laboratory test results as required by the study.
  • Must be able to understand and sign the informed consent form, communicate with the study doctor, and follow the study requirements.
  • Women who can become pregnant must have a negative pregnancy test before starting the study treatment and agree to use effective birth control and not donate eggs during the study and for 6 months after the last dose.
  • Men with partners who can become pregnant must agree to use effective birth control and not donate sperm during the study and for 6 months after the last dose.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer that is not Acute Myeloid Leukemia (AML) cannot participate. AML is a type of blood cancer.
  • Patients who have not experienced a return or persistence of AML after initial treatment are excluded. This means the study is for those whose AML has come back or did not go away after treatment.
  • Patients who are not adults cannot participate. The study is only for adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

  • L-Annamycin

    is a medication being tested in this clinical trial for its effectiveness in treating a type of blood cancer called acute myeloid leukemia (AML) that has not responded to previous treatments or has returned after treatment. It is given as an injection and works by targeting and killing cancer cells, which may help in achieving remission, meaning the cancer is reduced or disappears.

  • Cytarabine

    is another medication used in this trial, also given as an injection. It is a well-known treatment for AML and works by interfering with the growth of cancer cells, preventing them from multiplying. In this study, it is used in combination with L-Annamycin to see if the two drugs together can be more effective in treating AML than Cytarabine alone.

What is already known about the treatment

L-Annamycin – L-Annamycin is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML), particularly in patients whose disease has returned or not responded to initial treatment. It is being tested in combination with another medication called Cytarabine. The main goal is to find the best dose that helps achieve remission, which means reducing the cancer to an undetectable level. L-Annamycin works by interfering with the DNA of cancer cells, preventing them from growing and multiplying. It is classified as an anthracycline antibiotic, a type of chemotherapy drug.

Investigated diseases

Acute Myeloid Leukemia – 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 abnormal 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 of the disease requires prompt medical attention. It is most commonly diagnosed in adults, but it can occur at any age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518359-47-00Protocol codeMB-108Estimated enrolment312 patientsSponsorMoleculin Biotech Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).