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

Study Overview
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Brief Summary
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This observational study is designed to provide a better understanding of the potential use of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and of the potential of IFNγ as a therapeutic target in M-HLH.

Detailed Description
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This is a non-interventional 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.

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

Conditions
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Hemophagocytic Lymphohistiocytosis

Intervention / Treatment
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* Other: Blood Draws
* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malignancy-Associated Hemophagocytic Lymphohistiocytosis<br> | Other: Blood Draws<br> <br> Other: Data Collection<br> <br> |
| Absence of HLH in patients diagnosed with malignancy<br> | Other: Blood Draws<br> <br> Other: Data Collection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) |  | 6 months | 
| Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity |  | 6 months | 
| Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignancy-Associated Hemophagocytic Lymphohistiocytosis, Patients with known diagnosis of malignancy without HLH, Interferon Gamma, Biomarkers, Inflammatory Markers, Blood draws, Data collection, Hemophagocytic Lymphohistiocytosis, M-HLH, IFNγ