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

Hemophagocytic Lymphohistiocytosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytosis
  • Lymphohistiocytosis, Hemophagocytic
  • Neoplasms
Clinical Trial Details
NCT number NCT03259230
Study type Observational
Source NovImmune SA
Contact
Status Completed
Phase
Start date October 13, 2016
Completion date January 29, 2020
View Details
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