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

Last updated: December 9, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05277272
2021-0821
Sobi.HLH-RWE102
  • All Genders

Study Summary

The purpose of this observational study is to collect data on the natural history of disease of patients with Hemophagocytic Lymphohistiocytosis (HLH) including diagnosis, treatments, responses, and outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with clinically suspected or confirmed HLH, including those meeting theHLH-2004 diagnostic criteria (primary or secondary forms, including malignancy) andother forms of HLH (macrophage activation syndrome [MAS], cytokine release syndrome [CRS], etc.)

  • Signed and dated informed consent and assent (adolescents)

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 200
Study Start date:
December 31, 2021
Estimated Completion Date:
January 31, 2026

Study Description

Hemophagocytic Lymphohistiocytosis (HLH) is a complex, hyperinflammatory syndrome resulting from the interplay of genetic predisposition and various environmental factors. Despite available treatment options for HLH, approximately 30% of patients do not respond to therapy. Moreover, the standard therapy is constrained by its toxicities, and safer treatments are pursued.

There is an unmet need for a deeper understanding of the natural history, clinical/etiologic diversity, complications, and treatment outcomes of patients with HLH, specifically from North America. The proposed study, a collaboration between Cincinnati Children's Hospital Medical Center (CCHMC), Texas Children's Hospital, and Sobi Inc. aims to establish a robust registry that will enable investigators to better define the natural history of HLH.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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