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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-13

Study Completion Date

2020-01-29

Brief Summary

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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.

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Detailed Description

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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

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Hemophagocytic Lymphohistiocytosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Malignancy-Associated Hemophagocytic Lymphohistiocytosis

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

Blood Draws

Intervention Type OTHER

Data Collection

Intervention Type OTHER

Absence of HLH in patients diagnosed with malignancy

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).

Blood Draws

Intervention Type OTHER

Data Collection

Intervention Type OTHER

Interventions

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Blood Draws

Intervention Type OTHER

Data Collection

Intervention Type OTHER

Eligibility Criteria

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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