NCT03259230

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemophagocytic Lymphohistiocytosis

Interventions

Type	Name	Description
OTHER	Blood Draws
OTHER	Data Collection

Timeline

• Start date: 2016-10-13
• Primary completion: 2020-01-29
• Completion: 2020-01-29
• First posted: 2017-08-23
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States