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Study of luspatercept in patients with low-risk myelodysplastic syndrome (MDS) who do not require blood transfusions and have not received erythropoiesis 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 study focuses on patients with myelodysplastic syndromes (MDS), a group of blood disorders where the bone marrow does not produce enough healthy blood cells. The study specifically looks at patients with low-risk MDS who have anemia (low red blood cell counts) but do not need blood transfusions and have not previously received treatment with drugs that stimulate blood cell production.

The medication being tested is called luspatercept (Reblozyl), which is given as an injection under the skin. This treatment aims to improve the body's ability to produce red blood cells and increase hemoglobin levels in patients with MDS. The medication will be given to patients for up to 24 weeks to see if it can help improve their anemia.

The study will measure how well the treatment works by checking if patients' hemoglobin levels increase by a certain amount and if this improvement lasts for at least 8 weeks. Patients will receive subcutaneous injections of luspatercept at doses that may be adjusted during the study period. The treatment period may continue for up to 18 months for patients who show improvement in their condition.

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

    Initial treatment phase

    You will receive Reblozyl (luspatercept) through subcutaneous injection (under the skin).

    The treatment begins with an evaluation of your blood count, specifically your hemoglobin level (a protein that carries oxygen in your blood).

    Your starting hemoglobin level must be below 10 g/dL to begin the treatment.

  2. Step 2

    24-week evaluation period

    During the first 24 weeks, your blood counts will be monitored regularly.

    The main goal is to achieve an increase in your hemoglobin level by at least 1.5 g/dL.

    This improvement needs to last for at least 8 weeks to be considered successful.

  3. Step 3

    Extended monitoring phase

    If you respond positively to the treatment, monitoring will continue for up to 18 months.

    Regular blood tests will track how long the improvement in your hemoglobin levels lasts.

    The total duration of your participation may extend until April 2029.

  4. Step 4

    Treatment requirements

    You must have a diagnosis of myelodysplastic syndrome (MDS), a condition affecting blood cell production.

    Your MDS must be classified as very low-, low-, or intermediate-risk.

    You must not require regular blood transfusions when starting the treatment.

Who can join the trial?

8 criteria

  • Must be diagnosed with Myelodysplastic Syndromes (MDS) according to World Health Organization standards - a condition affecting blood cell production in bone marrow
  • Must have very low, low, or intermediate-risk MDS with a score up to 3.5 points on the IPSS-R classification (a system that helps determine the severity of the disease)
  • Must be non-transfusion dependent (NTD), which means not regularly requiring blood transfusions to manage the condition
  • Must have symptomatic anemia with average hemoglobin levels below 10 g/dL (indicating low red blood cell counts that cause symptoms)
  • Must be an adult (18 years or older)
  • Can be either male or female
  • Must not have received previous treatment with ESA (Erythropoiesis Stimulating Agents - medications that help produce red blood cells)
  • Must have anemia that requires medical attention but does not yet require regular blood transfusions

Who cannot join the trial?

15 criteria

  • Prior treatment with erythropoiesis-stimulating agents (ESAs) - medications that help produce red blood cells
  • Age below 18 years old
  • Presence of high-risk myelodysplastic syndrome (MDS)
  • Current need for regular blood transfusions
  • Previous treatment with luspatercept or similar medications
  • Active or uncontrolled infections
  • Significant heart, liver, or kidney problems
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Known allergic reactions to similar treatments
  • Presence of other types of cancer or blood disorders
  • Major surgery within the last 8 weeks
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Inability to provide informed consent
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Investigated drugs

Luspatercept is a medication that helps improve red blood cell production in people with myelodysplastic syndromes (MDS), a group of blood disorders. It works by helping the bone marrow produce more healthy red blood cells, which can help treat anemia. This medication is particularly useful for patients who haven't previously used other medications that stimulate red blood cell production and who don't need regular blood transfusions. It's given as an injection under the skin.

What is already known about the treatment

Luspatercept - A novel protein therapeutic administered through subcutaneous injection that regulates late-stage red blood cell maturation in bone marrow. This medication is currently being investigated in clinical trials for treating anemia in patients with myelodysplastic syndromes (MDS), particularly in those who haven't previously received erythropoiesis-stimulating agents (ESAs). Luspatercept works by binding to specific proteins in the TGF-beta superfamily, thereby promoting red blood cell development and helping to improve anemia symptoms. As a first-line treatment option for lower-risk MDS patients who don't require regular blood transfusions, it represents an innovative approach in hematological therapeutics and belongs to the class of erythroid maturation agents.

Investigated diseases

Myelodysplastic Syndromes (MDS) – A group of blood disorders where the bone marrow does not produce enough healthy blood cells. The condition occurs when blood-forming cells in the bone marrow become abnormal and have problems creating new blood cells. This leads to low numbers of one or more types of blood cells, with anemia being a common feature. MDS can affect people of any age but is more common in older adults. The condition develops gradually and causes blood cells to remain immature and fail to function properly. People with MDS often experience fatigue and weakness due to the decreased number of healthy blood cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516438-36-00Protocol codeLENNONEstimated enrolment30 patientsSponsorUniversitaet Leipzig

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