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INTO-HLH: A Registry for Hemophagocytic Lymphohistiocytosis (HLH)

This study is an observational registry for people with Hemophagocytic Lymphohistiocytosis (HLH), a rare and serious immune system disorder. The goal is to gather information about how HLH affects patients, including how it's diagnosed, the treatments they receive, and their health outcomes. Researchers want to better understand the disease's natural course, its different forms, complications, and how well treatments work, especially in North America. There are no specific interventions or drugs being tested in this study. You can participate if you have suspected or confirmed HLH, including those who meet the HLH-2004 diagnostic criteria or have other forms like macrophage activation syndrome (MAS) or cytokine release syndrome (CRS). The study aims to enroll 200 participants.

Study design
This is an observational study, meaning researchers will collect information about your condition without giving you a specific treatment. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track the time it takes to diagnose HLH (up to 6 months) and whether you have an autoimmune disease or cancer at the time of diagnosis (up to 1 month).

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

NCT05277272

INTO-HLH: A Disease Registry for Patients With Hemophagocytic Lymphohistiocytosis (HLH)

Recruiting
Not specifiedAll AgesObservational
Children's Hospital Medical Center, Cincinnati
~200 participants
Updated 2026-02-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to HLH diagnosis from the initial presentation
Measured over Interval between date of presentation, as defined as the day of appearance of initial HLH symptom, and the date of full HLH diagnosis, as defined by fulfilling the HLH diagnostic criteria, will be measured. Timeframes up to 6 months will be assessed.
+8 more outcomes measured

Conditions

Hemophagocytic Lymphohistiocytoses

Explore related trials

Hemophagocytic Lymphohistiocytosis

NCT05277272

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Jordan, MD · STUDY_CHAIR · Children's Hospital Medical Center, Cincinnati

Who to contact

Michael Jordan, MD
[email protected]
(513) 803-9063
Email the study team

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Eligibility criteria

Inclusion

Patients with clinically suspected or confirmed HLH, including those meeting the HLH-2004 diagnostic criteria (primary or secondary forms, including malignancy) and other forms of HLH (macrophage activation syndrome \[MAS\], cytokine release syndrome \[CRS\], etc.)
Signed and dated informed consent and assent (adolescents)

Exclusion

None

What this trial measures

  • Time to HLH diagnosis from the initial presentationInterval between date of presentation, as defined as the day of appearance of initial HLH symptom, and the date of full HLH diagnosis, as defined by fulfilling the HLH diagnostic criteria, will be measured. Timeframes up to 6 months will be assessed.

    Date of initial presentation and the date of HLH diagnosis as defined by HLH diagnostic criteria (HLH-2004/MAS classification criteria)

  • Number of patients with an autoimmune disease at the time of HLH diagnosisUp to 1 month from HLH diagnosis

    Presence of an autoimmune disease at the time of diagnosis (e.g., Systemic juvenile idiopathic arthritis, lupus)

  • Number of patients with malignancy at the time of HLH diagnosisUp to 1 month from HLH diagnosis.

    Presence of hematologic and solid malignancies at the time of HLH diagnosis.

  • Number of patients treated with immune-activating agents before HLH diagnosisUp to 1 month before HLH diagnosis.

    The number of patients treated with immune-activating agents before initial diagnosis (checkpoint inhibitors, CAR-T constructs)

  • Number of patients with central nervous system (CNS) involvement during the HLH disease course.Up to 1 month from HLH diagnosis.

    CNS involvement as defined by elevated neopterin, white blood cells, or protein at a cerebrospinal fluid or changes in MRI

  • Frequency of a genetic diagnosis underlying the HLH.Up to 1 month from HLH diagnosis.

    Data on genetic testing will be gathered and investigators will summarize the number to calculate the frequency of a genetic diagnosis.

  • Number of patients with infections (e.g., EBV, CMV, HHV6, HIV, fungal, bacterial) at the time of diagnosis.Up to 1 month from HLH diagnosis.

    The presence of infections at HLH diagnosis (serology and polymerase chain reaction).

  • Number of patients with organ failure.Up to 1 year from HLH diagnosis.

    Data will be gathered on organ failure related to HLH (e.g., kidney, lung, CNS).

  • Number of patients with long-term disease-related complications.Up to 5 years from HLH diagnosis.

    Data on long-term complications (e.g., impaired growth, impaired cognitive development) will be gathered.