Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05277272

Conditions

Hemophagocytic Lymphohistiocytoses

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Hemophagocytic Lymphohistiocytoses

Study ID

NCT05277272

Start date

Dec 31, 2021

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with clinically suspected or confirmed Hemophagocytic Lymphohistiocytosis

Multi-institutional cohort registry of patients with clinically suspected or confirmed Hemophagocytic Lymphohistiocytosis

Primary outcome measure

  • Time to HLH diagnosis from the initial presentation [ Time Frame: 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. ]
  • Number of patients with an autoimmune disease at the time of HLH diagnosis [ Time Frame: Up to 1 month from HLH diagnosis ]
  • Number of patients with malignancy at the time of HLH diagnosis [ Time Frame: Up to 1 month from HLH diagnosis. ]
  • Number of patients treated with immune-activating agents before HLH diagnosis [ Time Frame: Up to 1 month before HLH diagnosis. ]
  • Number of patients with central nervous system (CNS) involvement during the HLH disease course. [ Time Frame: Up to 1 month from HLH diagnosis. ]
  • Frequency of a genetic diagnosis underlying the HLH. [ Time Frame: Up to 1 month from HLH diagnosis. ]
  • Number of patients with infections (e.g., EBV, CMV, HHV6, HIV, fungal, bacterial) at the time of diagnosis. [ Time Frame: Up to 1 month from HLH diagnosis. ]
  • Number of patients with organ failure. [ Time Frame: Up to 1 year from HLH diagnosis. ]
  • Number of patients with long-term disease-related complications. [ Time Frame: Up to 5 years from HLH diagnosis. ]

Central Contacts and Locations

Central contacts

Michael Jordan, MD

(513) 803-9063Michael.Jordan@cchmc.org

Adi Zoref Lorenz, MD

Adi.Zoref.Lorenz@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Michael Jordan, MD

513-803-9063Michael.Jordan@cchmc.org

Principal Investigator:

Michael Jordan, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-24.