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 study about?

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.

1 Initial evaluation

Your eligibility for the study will be assessed based on specific medical criteria

A medical evaluation will confirm if you have Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Your organ function will be evaluated to ensure it is adequate for participation

Your physical condition will be assessed using the Eastern Cooperative Oncology Group (ECOG) scale, which must be 3 or lower

2 Treatment initiation

You will receive ELA026 medication through an intravenous infusion

The treatment will be administered in a medical facility

Your medical team will monitor your response to the treatment

3 Monitoring period – Day 1-29

Your medical condition will be regularly assessed for signs of HLH disease response

The medical team will monitor for any side effects

Your response to treatment will be evaluated using modified HLH-2004 criteria and biomarker criteria

4 Extended monitoring – Up to Day 90

Your survival status will be monitored at specific intervals: day 30, 45, 56, and 90

The medical team will continue to track your progress and any side effects

Your hospital discharge status will be documented

5 Study completion

Your participation in the study will be complete after the 90-day monitoring period

All treatment-related effects and outcomes will be documented

Who Can Join the Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Jena KöR Jena Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Stichting Radboud University Medical Center Nijmegen The Netherlands
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
Wmedtgyxqw Chwjwywyr Hdkvekuc Utrecht The Netherlands
Azphanfah Ubd Amsterdam The Netherlands
Eylyflr Uffjwflxaiiu Mxvewqj Clpzpyq Rhosdurou (odkaqjj Mva Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
30.04.2025
Italy Italy
Recruiting
30.04.2025
Spain Spain
Recruiting
30.04.2025
The Netherlands The Netherlands
Recruiting
30.04.2025

Trial locations

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.

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 ID:
2025-520624-25-00
Protocol code:
ELA026-CP002
Trial Phase:
Therapeutic use (Phase IV)

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