Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

Hemophagocytic Lymphohistiocytoses Clinical Trial

Official title:

An Observational, Multicenter Study to Evaluate Levels of Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Adult Patients With Hemophagocytic Lymphohistiocytosis (A-HLH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06047210
• Other study ID #: NI-0501-08
• Status: Completed
• Start date: December 14, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: September 2023
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.

Description:

This is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with HLH and to assess the relationship between the biomarkers and disease activity in these patients during the HLH course. Inflammatory markers include IFNγ and IFNγ-induced chemokines C-X-C chemokine ligand 9 and C-X-C chemokine ligand 10.

In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at HLH diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of HLH.

Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >=18 years old diagnosed with active HLH as established by the treating physician.

• HLH forms of unknown origin or secondary to infections or rheumatologic disorders.

• Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts.

• The patient must have consented to the use of their clinical data for research purposes at the site.

Exclusion Criteria:

• Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.

Related Conditions & MeSH terms

• Hemophagocytic Lymphohistiocytoses
• Lymphohistiocytosis, Hemophagocytic

Intervention

Other:
• Blood Draws Data Collection

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum	Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Concentrations of Inflammatory Markers in Participants Diagnosed With HLH	Serum samples were collected to determine the concentration of C-X-C chemokine ligand 10, C-X-C chemokine ligand 9, interferon gamma, interleukin 10, interleukin 1 beta, interleukin 6, neopterin, tumor necrosis factor alpha, Total human interferon gamma, soluble CD163 and soluble interleukin-2 receptor alpha.	11 months
Primary	Correlation Between Serum Concentrations of Inflammatory Markers and Markers of Disease Activity in Participants Diagnosed With HLH	Serum samples were collected to determine the markers of disease activity as indicated by the following laboratory assessments: albumin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, basophils, beta 2-microglobulin, total and conjugated bilirubin, blood urea nitrogen, serum creatinine, C-reactive protein, D-dimers, hemoglobin, hematocrit, red blood cells, white blood cells, and differential count, platelets, fasting triglycerides, ferritin, fibrinogen, lactate dehydrogenase, natural killer cell activity, prothrombin time and activated partial thromboplastin time, serum immunoglobulin G, Sodium.	11 months

External Links

•   Brigham and Women's Hospital