Back to search results

Observational Study of Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

This observational study aims to understand secondary Hemophagocytic Lymphohistiocytosis (sHLH), a severe immune disorder where your body's immune system doesn't work correctly, leading to fevers and illnesses. Researchers want to identify the immune system changes that cause sHLH and why some people develop it. This study is not testing a specific treatment, but rather gathering information to help develop better ways to diagnose and treat sHLH in the future. You may be eligible if you are an adult (18-120 years old) with an established diagnosis of sHLH based on specific medical criteria. The study will look at your medical records and collect blood samples to identify immune system mechanisms involved in sHLH.

Study design
This is an observational study with a planned enrollment of 300 participants. It is not testing an intervention or drug.
What's involved
You will have at least 3 clinical evaluations over 9 to 12 months. This includes three research blood draws, with the option for more at certain times.
Compensation
Not stated in the trial record.
Follow-up
Longitudinal clinical information will be recorded through the end of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06339177

Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study

Recruiting
Not specifiedAges 18+Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~300 participants
Updated 2026-03-20 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions.
Measured over Through end of study.

Conditions

Lymphohistiocytosis, Hemophagocytic
Secondary Hemophagocytic Lymphohistiocytosis
Macrophage Activation Syndrome
Hyperinflammatory Syndromes

Explore related trials

Macrophage Activation SyndromeSecondary Hemophagocytic LymphohistiocytosisStill DiseaseFerritinFibrinogenInterleukin-2 Receptor Subunit AlphaNK cell activityTriglycerides

Where it's being run

2 sites across 2 states
Maryland1
Pennsylvania1

Study leadership

  • Joseph M Rocco, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Joseph M Rocco, M.D.
[email protected]
(301) 312-2858
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Aged 18 years or older.
Established diagnosis of sHLH defined by meeting any published criteria, per Table 1:
Meeting the HLH-2004 criteria.
HScore of \>168. For those without a bone marrow biopsy to evaluate for hemophagocytosis (worth 35 points in the criteria), HScore\>134 will be used.
For those with underlying rheumatologic disease: meeting the 2016 American College of Rheumatology criteria for macrophage activation syndrome.
Agree to storage and sharing of study data and biospecimens for future research use.
Fever (\>38.4 Degrees Celcius)
Splenomegaly
Cytopenias affecting \>=2 of 3 lineages: Hgb \<9 g/dL, platelets \<10\^5/microliter, neutrophils \<10\^6/microliter
Hypertriglyceridemia (\>256 mg/dL) and/or fibrinogen \<1.5 g/L
Hemophagocytosis on biopsy
Serum ferritin \>=500 ng/mL
Increased serum sCD25 (\>2400 U/mL)
Low or absent NK cell activity
Platelets \<=181,000/microliter
AST \>48 IU/mL
Triglycerides \>156 mg/dL
Fibrinogen \<=3.6 g/L

Exclusion

Currently pregnant.
Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

What this trial measures

  • Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions.Through end of study.

    To study the immunopathogenesis of sHLH from various etiologies including biomarkers, cellular phenotypes, and gene expression to determine mechanistic pathways that may be amenable to host-directed therapies.