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Study on Luspatercept and Epoetin Alfa for Treating Anemia in Patients with Low to Intermediate Risk Myelodysplastic Syndromes Needing Blood Transfusions

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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 condition known as Myelodysplastic Syndromes (MDS), which affects the blood and bone marrow, leading to anemia, a condition where the body does not have enough healthy red blood cells. The study is comparing two treatments: Luspatercept, also known by its code name ACE-536, and Epoetin Alfa. Both treatments are given as injections under the skin and are designed to help increase the number of red blood cells in the body.

The purpose of the study is to evaluate how well Luspatercept works in helping patients become independent of red blood cell transfusions, compared to Epoetin Alfa. Participants in the study will receive either Luspatercept or Epoetin Alfa over a period of up to 24 weeks. During this time, the study will monitor the participants to see if they can maintain normal levels of hemoglobin, a protein in red blood cells that carries oxygen, without needing transfusions.

This study is important for people with Myelodysplastic Syndromes who have not previously been treated with erythropoiesis-stimulating agents (ESAs) and require regular red blood cell transfusions. The trial aims to provide insights into the effectiveness and safety of these treatments, potentially offering new options for managing anemia in patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

    You will be asked to sign an informed consent form, confirming your willingness to participate and adhere to the study requirements.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either luspatercept or epoetin alfa. This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    If assigned to luspatercept, you will receive it as a subcutaneous injection. The dosage will be either 25 mg or 75 mg, depending on your specific needs, and it will be administered every three weeks.

    If assigned to epoetin alfa, you will receive it as a subcutaneous injection. The dosage will be 4,000 IU/mL, 10,000 IU/mL, or 40,000 IU/mL, and it will be administered weekly.

  4. Step 4

    Regular visits

    You will attend regular visits to monitor your health and response to the treatment. These visits will include blood tests and assessments of your overall well-being.

    The frequency of these visits will be determined by the study protocol and your specific treatment plan.

  5. Step 5

    Evaluation of results

    Throughout the study, your response to the treatment will be evaluated. This includes measuring your hemoglobin levels and assessing your need for red blood cell transfusions.

    The primary goal is to determine if you can achieve independence from red blood cell transfusions for a period of 12 weeks, with an associated increase in hemoglobin levels.

  6. Step 6

    End of study

    At the end of the study, you will have a final visit to assess your health and discuss the outcomes of your participation.

    You will receive information about any follow-up care or additional studies that may be available to you.

Who can join the trial?

9 criteria

  • You must be at least 18 years old.
  • You need to understand and sign a consent form before any study activities begin.
  • You should be willing and able to follow the study schedule and requirements.
  • You must have a confirmed diagnosis of myelodysplastic syndrome (MDS) with a specific risk level (very low, low, or intermediate) and less than 5% abnormal cells (blasts) in your bone marrow.
  • Your natural level of a hormone called erythropoietin (which helps make red blood cells) should be less than 500 U/L.
  • You need regular red blood cell transfusions, specifically 2 to 6 units every 8 weeks, and your hemoglobin level (a measure of red blood cells) should be low enough to need these transfusions.
  • Your Eastern Cooperative Oncology Group (ECOG) score, which measures your ability to perform daily activities, should be 0, 1, or 2.
  • If you are a woman who can have children, you must have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing. You must also agree to use effective birth control or abstain from heterosexual contact during the study and for 12 weeks after.
  • If you are a man, you must agree to use a condom during sexual contact with a woman who can have children or is pregnant, or practice abstinence during the study and for 12 weeks after.

Who cannot join the trial?

4 criteria

  • Patients who have been diagnosed with a condition other than myelodysplastic syndrome (MDS) cannot participate. MDS is a group of disorders caused by poorly formed or dysfunctional blood cells.
  • Patients who have previously been treated with erythropoiesis stimulating agents (ESA) are not eligible. ESAs are medications that help the body produce more red blood cells.
  • Patients who do not require red blood cell transfusions are excluded. A red blood cell transfusion is a procedure where red blood cells are given to a patient through a vein.
  • Patients with a different type of anemia than the one specified in the study are not eligible. Anemia is a condition where you don't have enough healthy red blood cells to carry adequate oxygen to your body's tissues.
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Investigated drugs

  • Luspatercept

    is a medication being studied for its ability to help people with a type of blood disorder called myelodysplastic syndromes (MDS). This disorder can cause anemia, which means the body doesn't have enough healthy red blood cells. Luspatercept works by helping the body produce more red blood cells, which can reduce the need for blood transfusions. In this trial, researchers are looking at how well luspatercept can help patients become independent of red blood cell transfusions and increase their hemoglobin levels, which is a protein in red blood cells that carries oxygen.

  • Epoetin Alfa

    is another medication used in this study to treat anemia in patients with myelodysplastic syndromes (MDS). It is a type of drug known as an erythropoiesis-stimulating agent (ESA), which means it helps the body make more red blood cells. By increasing the production of red blood cells, epoetin alfa can help reduce the need for blood transfusions in patients with anemia. The trial is comparing the effectiveness and safety of epoetin alfa with luspatercept to see which one is better at helping patients with MDS manage their anemia.

What is already known about the treatment

  • Luspatercept

    Luspatercept is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating anemia in patients with myelodysplastic syndromes (MDS), a group of disorders caused by poorly formed or dysfunctional blood cells. The medication works by helping the body produce more red blood cells, which can reduce the need for blood transfusions. Luspatercept is classified as an erythroid maturation agent, which means it helps mature red blood cells in the bone marrow.

  • Epoetin Alfa

    Epoetin Alfa is given as an injection, either under the skin or into a vein, and is used to treat anemia by stimulating the production of red blood cells. It is currently being compared to Luspatercept in clinical trials for patients with myelodysplastic syndromes (MDS) who have not previously been treated with erythropoiesis-stimulating agents. Epoetin Alfa works by mimicking a natural hormone in the body called erythropoietin, which signals the bone marrow to produce more red blood cells. It is classified as an erythropoiesis-stimulating agent.

Investigated diseases

Myelodysplastic syndrome (MDS) – Myelodysplastic syndrome is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes less effective at producing healthy blood cells, leading to anemia, infections, or bleeding. The disease progresses as the bone marrow produces more abnormal cells, which can crowd out healthy cells. This can result in a shortage of red blood cells, white blood cells, and platelets. As the condition advances, it may lead to more severe symptoms and complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501485-22-00Protocol codeACE-536-MDS-002Estimated enrolment363 patientsSponsorCelgene Corp.

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