Registry for patients with Hemophagocytic Lymphohistiocytosis

INTO-HLH- Insight Into the Natural History and Treatment Outcomes of Hemophagocytic Lymphohistiocytosis (HLH): A Disease Registry for Patients With HLH

Observational Children's Hospital Medical Center, Cincinnati · NCT05277272

This study is collecting information from patients with Hemophagocytic Lymphohistiocytosis to better understand the condition and improve future treatments.

Quick facts

Study typeObservational
Enrollment200 (estimated)
SexAll
SponsorChildren's Hospital Medical Center, Cincinnati Academic / other
Locations1 site (Cincinnati, Ohio)
Trial IDNCT05277272 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect comprehensive data on the natural history of Hemophagocytic Lymphohistiocytosis (HLH), including aspects such as diagnosis, treatment responses, and patient outcomes. The study seeks to address the significant gaps in understanding the clinical diversity and complications associated with HLH, particularly in North America. By establishing a robust registry, the collaboration between Cincinnati Children's Hospital Medical Center, Texas Children's Hospital, and Sobi Inc. will facilitate better insights into HLH and potentially guide future treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study include patients with clinically suspected or confirmed HLH, including those meeting the HLH-2004 diagnostic criteria.

Not a fit: Patients who do not have clinically suspected or confirmed HLH will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved understanding and management of HLH, ultimately enhancing patient outcomes.

How similar studies have performed: While there have been studies on HLH, this registry approach is novel in its comprehensive data collection focused on the North American population.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* None

Where this trial is running

Cincinnati, Ohio

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Hemophagocytic Lymphohistiocytoses
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.