Skip to main content
OpenTrials
Completed

NCT Number: NCT03259230

Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis

This observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

This is a observational study designed to determine the levels of inflammatory markers in patients diagnosed with M-HLH and to assess the relationship between the biomarkers and disease activity in these patients during the M-HLH course. Inflammatory markers will also be measured in a group of control patients diagnosed with hematological malignancy but without HLH. Inflammatory markers include IFNγ and IFNγ-induced chemokines CXCL9 and CXCL10.

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 M-HLH diagnosis, at regular time intervals during the treatment course as well as at resolution or reactivation of the disease.

Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before participant's samples are sent to the sponsor for testing, participant'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 diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH will be established by the treating physician.
  • The patient or patient's legal representative (in case the patient is < 18 years old) must have consented to the use of their clinical data for research purposes at the site.
  • For the control group, patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH

Exclusion criteria

N/A

Treatment and study plan

Blood draws

Other

Data Collection

Other

Primary outcomes

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

    Time frame: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 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: From Day 1 up to 39.5 months

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

  12. Mean Serum Concentration of Hemoglobin

    Time frame: From Day 1 up to 39.5 months

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

  13. Mean Serum Concentration of Hematocrit

    Time frame: From Day 1 up to 39.5 months

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

  14. Mean Serum Concentration of Erythrocytes

    Time frame: From Day 1 up to 39.5 months

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

  15. Mean Serum Concentration of Leukocytes

    Time frame: From Day 1 up to 39.5 months

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

  16. Mean Serum Concentration of Neutrophils

    Time frame: From Day 1 up to 39.5 months

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

  17. Mean Serum Concentration of Lymphocytes

    Time frame: From Day 1 up to 39.5 months

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

  18. Mean Serum Concentration of Monocytes

    Time frame: From Day 1 up to 39.5 months

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

  19. Mean Serum Concentration of Eosinophils

    Time frame: From Day 1 up to 39.5 months

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

  20. Mean Serum Concentration of Basophils

    Time frame: From Day 1 up to 39.5 months

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

  21. Mean Serum Concentration of Platelets

    Time frame: From Day 1 up to 39.5 months

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

  22. Mean Plasma Concentration of Fibrinogen

    Time frame: From Day 1 up to 39.5 months

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

  23. Mean Plasma Concentration of D-Dimer

    Time frame: From Day 1 up to 39.5 months

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

  24. Mean Serum Concentration of Ferritin

    Time frame: From Day 1 up to 39.5 months

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

  25. Mean Serum Concentration of Fasting Triglycerides

    Time frame: From Day 1 up to 39.5 months

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

  26. Mean Serum Concentration of Creatinine

    Time frame: From Day 1 up to 39.5 months

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

  27. Mean Plasma Concentration of Blood Urea Nitrogen

    Time frame: From Day 1 up to 39.5 months

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

  28. Mean Serum Concentration of Albumin

    Time frame: From Day 1 up to 39.5 months

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

  29. Mean Serum Concentration of Sodium

    Time frame: From Day 1 up to 39.5 months

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

  30. Mean Serum Concentration of Beta2-Microglobulin

    Time frame: From Day 1 up to 39.5 months

    Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin.

  31. Mean Serum Concentration of Immunoglobulin G (IgG)

    Time frame: From Day 1 up to 39.5 months

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

  32. Mean Serum Concentration of C-Reactive Protein

    Time frame: From Day 1 up to 39.5 months

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

  33. Mean Serum Concentration of Aspartate Aminotransferase

    Time frame: From Day 1 up to 39.5 months

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

  34. Mean Serum Concentration of Alanine Aminotransferase

    Time frame: From Day 1 up to 39.5 months

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

  35. Mean Serum Concentration of Alkaline Phosphatase

    Time frame: From Day 1 up to 39.5 months

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

  36. Mean Serum Concentration of Lactate Dehydrogenase

    Time frame: From Day 1 up to 39.5 months

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

  37. Mean Serum Concentration of Total Bilirubin

    Time frame: From Day 1 up to 39.5 months

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

  38. Mean Serum Concentration of Conjugated Bilirubin

    Time frame: From Day 1 up to 39.5 months

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

  39. Mean Serum Concentration of Natural Killer (NK) Cell Activity

    Time frame: From Day 1 up to 39.5 months

    Blood samples was collected at various times after HLH diagnosis to determine the concentration of NK cell activity. A lytic unit 30 (LU30) was defined as the number of effector cells necessary to cause lysis of 30% of its target cells.

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2017
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.