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Study on Canakinumab for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes or MDS/MPN

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 clinical trial is focused on studying a group of blood disorders known as myelodysplastic syndromes (MDS) and a related condition called myelodysplastic/myeloproliferative neoplasms (MDS/MPN). These conditions can lead to anemia, which is a shortage of red blood cells that can cause fatigue and weakness. The trial is testing a treatment called canakinumab, which is given as a solution for injection under the skin. Canakinumab is being studied to see if it can help improve anemia in patients with lower-risk MDS or MDS/MPN.

The purpose of the study is to assess how well canakinumab works and how safe it is for patients with these conditions. Participants in the study will receive canakinumab over a period of time, and their response to the treatment will be monitored. The study will look at whether there is an improvement in hemoglobin levels, which is a measure of red blood cells in the blood, and whether this improvement lasts for at least eight weeks. The study will also observe if patients can avoid needing blood transfusions during this time.

This trial is open-label, meaning both the researchers and participants know that canakinumab is being administered. The study is designed to gather information on the effectiveness of canakinumab in treating anemia associated with lower-risk MDS or MDS/MPN, providing valuable insights into potential new treatment options for these conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a confirmed diagnosis of lower-risk MDS or MDS/MPN is required. This includes specific subtypes as per the World Health Organization classification.
Eligibility is determined by specific criteria, including age (18 years or older), symptomatic anemia, and previous treatment history.
Written informed consent is necessary to participate.
Step 2
Treatment initiation
The treatment involves the administration of canakinumab, a medication provided as a solution for injection.
The medication is administered through subcutaneous use, which means it is injected under the skin.
Step 3
Treatment schedule
The treatment consists of 8 cycles of canakinumab.
The primary goal is to achieve an increase in hemoglobin levels by at least 1.5 g/dL, sustained for at least 8 weeks, or to avoid transfusions within an 8-week period.
Step 4
Monitoring and assessment
Throughout the trial, regular monitoring of hemoglobin levels and overall health is conducted to assess the effectiveness and safety of the treatment.
The primary endpoint is determined after the completion of the 8 cycles of treatment.
Step 5
Completion of the trial
The trial is estimated to conclude by December 29, 2028.
Upon completion, the results will be evaluated to determine the efficacy and safety of canakinumab for the treatment of anemia in patients with lower-risk MDS or MDS/MPN.

Who can join the trial?

6 criteria

Have a confirmed diagnosis of **lower-risk MDS** or **MDS/MPN**. This includes specific types like MDS/MPN-RS-T, MDS/MPNu, aCML, or CMML, according to the World Health Organization's 2016 classification.
Have an **IPSS-R score** up to 3.5, which means the disease is considered very low, low, or intermediate risk. For MDS/MPN, there should be less than 10% **bone marrow blasts**. For CMML, the **CPSS-Score** should be low or intermediate.
Experience **symptomatic anemia**, which is a condition where there are not enough healthy red blood cells, based on your hemoglobin levels and history of blood transfusions.
Have relapsed, are refractory, intolerant, or ineligible for **ESA treatment**. This means the body does not respond well to or cannot use a specific treatment for anemia.
Be **18 years or older**.
Provide **written informed consent**, which means you agree to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

Patients with a different type of blood disorder than the one being studied.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who do not meet the specific health conditions required for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other medical conditions that might interfere with the study.
Patients who are taking medications that could affect the study results.
Patients who have had recent treatments that might impact the study.
Patients who are pregnant or breastfeeding, as the study might not be safe for them.
Patients who have a history of allergic reactions to the study medication.

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Verified sites

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Universitaet Leipzig
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Leipzig, Germany

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Investigated drugs

Canakinumab is a medication being studied for its ability to treat anemia in patients with certain types of blood disorders, specifically myelodysplastic syndromes (MDS) and myelodysplastic/myeloproliferative neoplasms (MDS/MPN). The trial aims to evaluate how well this medication can improve the production of red blood cells in patients with these conditions.

Canakinumab

What is already known about the treatment

Canakinumab – Canakinumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating anemia in patients with certain types of blood disorders, specifically lower-risk myelodysplastic syndromes (MDS) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN). The medication works by targeting and blocking a specific protein in the body that can cause inflammation, which may help improve red blood cell production. Canakinumab is classified as an interleukin-1 beta inhibitor, a type of medication that reduces inflammation by interfering with the action of interleukin-1 beta, a molecule involved in inflammatory responses.

Investigated diseases

Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes are a group of disorders caused by poorly formed or dysfunctional blood cells. These conditions occur when the bone marrow does not produce enough healthy blood cells, leading to symptoms like fatigue, infections, and easy bruising. Over time, MDS can progress to more severe forms of anemia or other blood-related issues. The risk level of MDS can vary, with some cases being lower-risk and others more severe. The progression of the disease can lead to a need for regular blood transfusions or other supportive care. MDS is often diagnosed in older adults and can be associated with genetic mutations or previous chemotherapy treatments.
Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN)
Myelodysplastic/myeloproliferative neoplasms are a group of diseases that have features of both myelodysplastic syndromes and myeloproliferative disorders. These conditions are characterized by the abnormal production of blood cells, which can lead to a variety of symptoms such as fatigue, fever, and weight loss. The bone marrow produces too many or too few of certain types of blood cells, which can cause complications like anemia or an increased risk of bleeding. MDS/MPN can progress slowly, but the course of the disease can vary widely among individuals. The condition is often identified through blood tests and bone marrow examinations. It is more common in older adults and can be associated with genetic changes in the blood cells.