Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

NCT06047210 | Completed Results

• 1 other identifier: NI-0501-08
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemophagocytic Lymphohistiocytoses

Keywords

Hemophagocytic Lymphohistiocytosis; Interferon Gamma; IFNγ; Biomarkers; Inflammatory Markers

Outcome Measures

Primary Outcomes (39)

• Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Neopterin

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.

  11 months

• Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.

  11 months

• Mean Serum Concentration of White Blood Cells

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.

  11 months

• Mean Serum Concentration of Red Blood Cells

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.

  11 months

• Mean Serum Concentration of Hemoglobin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.

  11 months

• Mean Serum Concentration of Hematocrit

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.

  11 months

• Mean Serum Concentration of Platelets

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.

  11 months

• Mean Serum Concentration of Neutrophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.

  11 months

• Mean Serum Concentration of Lymphocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.

  11 months

• Mean Serum Concentration of Monocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.

  11 months

• Mean Serum Concentration of Eosinophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.

  11 months

• Mean Serum Concentration of Basophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.

  11 months

• Mean Plasma Concentration of D-Dimer

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.

  11 months

• Mean Plasma Concentration of Fibrinogen

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.

  11 months

• Mean Activated Partial Thromboplastin Time (aPTT)

  Blood samples was collected at various times after HLH diagnosis to determine the aPTT.

  11 months

• Mean Prothrombin Time

  Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.

  11 months

• Mean Serum Concentration of C-Reactive Protein

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.

  11 months

• Mean Serum Concentration of Ferritin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.

  11 months

• Mean Plasma Concentration of Blood Urea Nitrogen

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.

  11 months

• Mean Serum Concentration of Creatinine

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.

  11 months

• Mean Serum Concentration of Albumin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.

  11 months

• Mean Serum Concentration of Sodium

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.

  11 months

• Mean Serum Concentration of Fasting Triglycerides

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.

  11 months

• Mean Serum Concentration of Total Bilirubin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.

  11 months

• Mean Serum Concentration of Conjugated Bilirubin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.

  11 months

• Mean Serum Concentration of Alanine Aminotransferase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.

  11 months

• Mean Serum Concentration of Aspartate Aminotransferase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.

  11 months

• Mean Serum Concentration of Alkaline Phosphatase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.

  11 months

• Mean Serum Concentration of Lactate Dehydrogenase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.

  11 months

• Mean Serum Concentration of Immunoglobulin G (IgG)

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.

  11 months

Study Arms (2)

A-HLH Patients

Patients diagnosed with A-HLH.

Other: Blood Draws Data Collection

Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients

Patients diagnosed with HLH in the context of a malignancy.

Other: Blood Draws Data Collection

Interventions

Blood Draws Data Collection OTHER

A-HLH Patients; Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female adult (\>=18 years old) patients who are diagnosed with HLH and meet the inclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• Brigham and Women's Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Brigham and Women's Hospital

Biospecimen

Retention: SAMPLES WITH DNA

For biomarker analysis a maximum of 5 milliliter (mL) of whole blood was required per time point.

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Swedish Orphan Biovitrum

clinical@sobi.com

+4686972000

Study Officials

• Nancy Berliner, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 21, 2023
• Study Start: December 14, 2016
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

US (1)