Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Interventions
- Other: Blood DrawsOther: Data Collection
- Registration Number
- NCT03259230
- Lead Sponsor
- Light Chain Bioscience - Novimmune SA
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Malignancy-Associated Hemophagocytic Lymphohistiocytosis Blood Draws Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH was established by the treating physician. Malignancy-Associated Hemophagocytic Lymphohistiocytosis Data Collection Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH was established by the treating physician. Absence of HLH in patients diagnosed with malignancy Blood Draws 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). Absence of HLH in patients diagnosed with malignancy Data Collection 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).
- Primary Outcome Measures
Name Time Method Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Mean Serum Concentration of Inflammatory Biomarker - Neopterin From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) From Day 1 up to 39.5 months Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Mean Serum Concentration of Hemoglobin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Mean Serum Concentration of Hematocrit From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Mean Serum Concentration of Erythrocytes From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes.
Mean Serum Concentration of Leukocytes From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes.
Mean Serum Concentration of Neutrophils From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Mean Serum Concentration of Lymphocytes From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Mean Serum Concentration of Monocytes From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Mean Serum Concentration of Eosinophils From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Mean Serum Concentration of Basophils From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Mean Serum Concentration of Platelets From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Mean Plasma Concentration of Fibrinogen From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Mean Plasma Concentration of D-Dimer From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Mean Serum Concentration of Ferritin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Mean Serum Concentration of Fasting Triglycerides From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Mean Serum Concentration of Creatinine From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Mean Plasma Concentration of Blood Urea Nitrogen From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Mean Serum Concentration of Albumin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Mean Serum Concentration of Sodium From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Mean Serum Concentration of Beta2-Microglobulin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin.
Mean Serum Concentration of Immunoglobulin G (IgG) From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Mean Serum Concentration of C-Reactive Protein From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Mean Serum Concentration of Aspartate Aminotransferase From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Mean Serum Concentration of Alanine Aminotransferase From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Mean Serum Concentration of Alkaline Phosphatase From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Mean Serum Concentration of Lactate Dehydrogenase From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Mean Serum Concentration of Total Bilirubin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Mean Serum Concentration of Conjugated Bilirubin From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Mean Serum Concentration of Natural Killer (NK) Cell Activity From Day 1 up to 39.5 months Blood samples was collected at various times after HLH diagnosis to determine the concentration of NK cell activity. A lytic unit 30 (LU30) was defined as the number of effector cells necessary to cause lysis of 30% of its target cells.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States