Amsterdam UMC
Amsterdam, The Netherlands
RecruitingRare disease
Study of ELA026 for Treatment of Secondary Hemophagocytic Lymphohistiocytosis in Patients with Lymphoma Who Have Not Received Previous Treatment
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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 Secondary Hemophagocytic Lymphohistiocytosis (sHLH), a severe condition where the immune system becomes overactive and damages the body's own tissues. The study will test a new medication called ELA026, which is given through intravenous infusion. The purpose is to evaluate how well this treatment works in patients who have sHLH that developed as a result of having lymphoma, a type of blood cancer.
The study will monitor patients who receive ELA026 for up to 90 days to assess their response to treatment. The main focus will be on checking if patients survive for at least 56 days after starting treatment. During the study, patients will receive the medication through an intravenous line, and their condition will be closely monitored by healthcare professionals.
Throughout the treatment period, which may last up to 85 days, doctors will track how well patients respond to ELA026 by looking at various signs of improvement in their condition. They will also monitor for any side effects that might occur during the treatment. This is an open-label study, which means both doctors and patients will know which treatment is being given.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Must be diagnosed with Secondary Hemophagocytic Lymphohistiocytosis (sHLH) - a rare blood disorder where the immune system becomes overactive
- Must have adequate organ function that allows participation in the clinical trial, considering the underlying disease
- Must have an ECOG score of 3 or less (ECOG measures a person's ability to perform daily activities, where 0 means fully active and 3 means capable of only limited self-care and confined to bed or chair more than 50% of waking hours)
- Must be able to provide signed informed consent, or have a legally authorized representative who can provide consent
- For participants who are minors (under 18 years old): must be able to provide written assent as required by local regulations, along with parent/guardian consent
- Both male and female participants can join the study
- Adults, adolescents, and children can participate in the study
- For Cohort A participants: must be treatment-naive (not previously treated) and have lymphoma as the cancer trigger
Who cannot join the trial?
13 criteria
- Patients who are younger than 18 years of age
- Patients with active infections that require treatment
- Patients with severe liver dysfunction (poor liver function)
- Patients who received other experimental treatments within 30 days before starting this study
- Patients with uncontrolled heart conditions (such as unstable heart disease or recent heart attack)
- Pregnant or breastfeeding women
- Patients who have participated in another clinical trial within the past 30 days
- Patients with known allergies to the study medication or its components
- Patients with severe kidney dysfunction (poor kidney function)
- Patients who cannot give informed consent
- Patients with other types of cancer that require immediate treatment
- Patients with severe mental health conditions that could interfere with the study
- Patients who are unable to follow study procedures or attend required visits
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Verified sites
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Responsive Verified Azienda Ospedaliera di Padova
Padua, ItalyResponsive Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Trial locations
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Investigated drugs
ELA026 is an investigational medication being studied for the treatment of Secondary Hemophagocytic Lymphohistiocytosis (sHLH), a severe condition where the immune system becomes overactive. This medication is being tested in patients who have not received previous treatment and have lymphoma (a type of blood cancer) that triggered their condition. The medication aims to help control the excessive immune response and improve survival rates in these patients.
What is already known about the treatment
ELA026 - An investigational medication being studied in clinical trials for the treatment of Secondary Hemophagocytic Lymphohistiocytosis (sHLH), particularly in patients with lymphoma triggers who haven't received previous treatment. The medication is currently undergoing Phase 2/3 clinical trials to evaluate its safety and effectiveness in improving survival rates in sHLH patients. While the specific mechanism of action and administration form are not publicly disclosed in the current trial data, this experimental treatment is being studied in an open-label, single-arm multicenter study comparing results against historical control data.
Note: Due to the early stage of clinical research and limited publicly available information, some specific details about the medication's properties and administration method cannot be provided.
Investigated diseases
Secondary Hemophagocytic Lymphohistiocytosis (sHLH) – A rare inflammatory disorder that occurs as a result of an underlying condition, most commonly triggered by cancer, infections, or autoimmune diseases. In this condition, the immune system becomes overactive and produces too many activated immune cells that accumulate in various organs. These cells cause inflammation and damage to organs, including the liver, spleen, and bone marrow. The condition affects the body's ability to produce normal blood cells and can lead to abnormal blood cell counts. The disease typically develops rapidly with symptoms such as persistent fever, enlarged liver and spleen, and decreased blood cell counts.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520624-25-00Protocol codeELA026-CP002Estimated enrolment100 patientsSponsorElectra Therapeutics Inc.
sourced from the EU Clinical Trials Register and site verification
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