Clinical trial NCT03259230: Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
Official title: An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Hemophagocytic Lymphohistiocytosis
Malignancy-Associated Hemophagocytic Lymphohistiocytosis
M-HLH
Patients with known diagnosis of malignancy without HLH
Interferon Gamma
IFNγ
Biomarkers
Inflammatory Markers
Blood draws
Data collection
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2017-08-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female (adult and children) patients who are diagnosed with M-HLH and that meet the inclusion criteria. In addition, patients with a diagnosis of hematological malignancy in the absence of HLH will be included as a control group.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Neopterin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Hemoglobin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Hematocrit
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Erythrocytes
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Leukocytes
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Neutrophils
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Lymphocytes
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Monocytes
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Eosinophils
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Basophils
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Platelets
timeFrame: From Day 1 up to 39.5 months
measure: Mean Plasma Concentration of Fibrinogen
timeFrame: From Day 1 up to 39.5 months
measure: Mean Plasma Concentration of D-Dimer
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Ferritin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Fasting Triglycerides
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Creatinine
timeFrame: From Day 1 up to 39.5 months
measure: Mean Plasma Concentration of Blood Urea Nitrogen
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Albumin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Sodium
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Beta2-Microglobulin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Immunoglobulin G (IgG)
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of C-Reactive Protein
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Aspartate Aminotransferase
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Alanine Aminotransferase
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Alkaline Phosphatase
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Lactate Dehydrogenase
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Total Bilirubin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Conjugated Bilirubin
timeFrame: From Day 1 up to 39.5 months
measure: Mean Serum Concentration of Natural Killer (NK) Cell Activity
timeFrame: From Day 1 up to 39.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Naval Daver, MD
role: PRINCIPAL_INVESTIGATOR
References: