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

Sponsor

Light Chain Bioscience - Novimmune SA (Industry)

Overall Status

Completed

CT.gov ID

NCT03259230

Collaborator

M.D. Anderson Cancer Center (Other)

Enrollment

Location

39.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemophagocytic Lymphohistiocytosis	Other: Blood Draws Other: Data Collection

Detailed 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

Study Type:

Observational

Actual Enrollment :

32 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 13, 2016

Actual Primary Completion Date :

Jan 29, 2020

Actual Study Completion Date :

Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Malignancy-Associated Hemophagocytic Lymphohistiocytosis	Other: Blood Draws Other: Data Collection
Absence of HLH in patients diagnosed with malignancy	Other: Blood Draws Other: Data Collection

Arm

Intervention/Treatment

Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Other: Blood Draws

Other: Data Collection

Absence of HLH in patients diagnosed with malignancy

Other: Blood Draws

Other: Data Collection

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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