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

Sobi

Status: Completed

Conditions: Hemophagocytic Lymphohistiocytosis

Treatments: Other: Blood Draws; Other: Data Collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03259230

NI-0501-07

PA16-0129 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH will be established by the treating physician.
2. 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.
3. 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

Trial design

40 participants in 2 patient groups

Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Description:

Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH was established by the treating physician.

Treatment:

Other: Data Collection

Other: Blood Draws

Absence of HLH in patients diagnosed with malignancy

Description:

Patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample).

Treatment:

Other: Data Collection

Other: Blood Draws