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Completed

NCT Number: NCT06047210

Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

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.

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Key information

Conditions

Hemophagocytic Lymphohistiocytoses Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Non-Langerhans-Cell Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Draws Data Collection

Other

Primary outcomes

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

  7. Mean Serum Concentration of Inflammatory Biomarker - Neopterin

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

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

    Time frame: 11 months

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

  12. Mean Serum Concentration of White Blood Cells

    Time frame: 11 months

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

  13. Mean Serum Concentration of Red Blood Cells

    Time frame: 11 months

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

  14. Mean Serum Concentration of Hemoglobin

    Time frame: 11 months

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

  15. Mean Serum Concentration of Hematocrit

    Time frame: 11 months

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

  16. Mean Serum Concentration of Platelets

    Time frame: 11 months

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

  17. Mean Serum Concentration of Neutrophils

    Time frame: 11 months

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

  18. Mean Serum Concentration of Lymphocytes

    Time frame: 11 months

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

  19. Mean Serum Concentration of Monocytes

    Time frame: 11 months

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

  20. Mean Serum Concentration of Eosinophils

    Time frame: 11 months

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

  21. Mean Serum Concentration of Basophils

    Time frame: 11 months

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

  22. Mean Plasma Concentration of D-Dimer

    Time frame: 11 months

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

  23. Mean Plasma Concentration of Fibrinogen

    Time frame: 11 months

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

  24. Mean Activated Partial Thromboplastin Time (aPTT)

    Time frame: 11 months

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

  25. Mean Prothrombin Time

    Time frame: 11 months

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

  26. Mean Serum Concentration of C-Reactive Protein

    Time frame: 11 months

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

  27. Mean Serum Concentration of Ferritin

    Time frame: 11 months

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

  28. Mean Plasma Concentration of Blood Urea Nitrogen

    Time frame: 11 months

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

  29. Mean Serum Concentration of Creatinine

    Time frame: 11 months

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

  30. Mean Serum Concentration of Albumin

    Time frame: 11 months

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

  31. Mean Serum Concentration of Sodium

    Time frame: 11 months

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

  32. Mean Serum Concentration of Fasting Triglycerides

    Time frame: 11 months

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

  33. Mean Serum Concentration of Total Bilirubin

    Time frame: 11 months

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

  34. Mean Serum Concentration of Conjugated Bilirubin

    Time frame: 11 months

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

  35. Mean Serum Concentration of Alanine Aminotransferase

    Time frame: 11 months

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

  36. Mean Serum Concentration of Aspartate Aminotransferase

    Time frame: 11 months

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

  37. Mean Serum Concentration of Alkaline Phosphatase

    Time frame: 11 months

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

  38. Mean Serum Concentration of Lactate Dehydrogenase

    Time frame: 11 months

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

  39. Mean Serum Concentration of Immunoglobulin G (IgG)

    Time frame: 11 months

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

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • Brigham and Women's Hospital
  • Harvard Medical School (HMS and HSDM)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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