Hemophagocytic Lymphohistiocytosis
Conditions
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
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.
Interventions
OTHERBlood Draws
OTHERData Collection
Sponsors
M.D. Anderson Cancer Center
Swedish Orphan Biovitrum
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
United States
Participant flow
Recruitment details
This Phase 4 observational study was conducted in patients diagnosed with malignancy-associated hemophagocytic lymphohistiocytosis (M-HLH) at a single center in the United States of America.
Pre-assignment details
A total of 40 patients were enrolled in the study. Of which 39 patients had a confirmed malignancy and were included in the malignancy set for analysis.
Participants by arm
| Arm | Count |
|---|---|
| HLH Patients All patients diagnosed with HLH in the context of a malignancy. | 19 |
| Non-HLH Patients All 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). | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from the Malignancy Analysis Set | 1 | 0 |
Baseline characteristics
| Characteristic | HLH Patients | Non-HLH Patients | Total |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 18.6 | 63.2 years STANDARD_DEVIATION 15.3 | 60.0 years STANDARD_DEVIATION 17.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Plasma Concentration of Blood Urea Nitrogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Plasma Concentration of Blood Urea Nitrogen | 44.68 mg/dL | Standard Deviation 30.53 |
| Non-HLH Patients | Mean Plasma Concentration of Blood Urea Nitrogen | 29.00 mg/dL | Standard Deviation 3.92 |
Primary
Mean Plasma Concentration of D-Dimer
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Plasma Concentration of D-Dimer | 10.165 microgram (mcg)/mL | Standard Deviation 7.569 |
| Non-HLH Patients | Mean Plasma Concentration of D-Dimer | 2.220 microgram (mcg)/mL | Standard Deviation 2.107 |
Primary
Mean Plasma Concentration of Fibrinogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Plasma Concentration of Fibrinogen | 207.5 milligram (mg)/dL | Standard Deviation 143 |
| Non-HLH Patients | Mean Plasma Concentration of Fibrinogen | 357.5 milligram (mg)/dL | Standard Deviation 2.1 |
Primary
Mean Serum Concentration of Alanine Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Alanine Aminotransferase | 127.9 IU/L | Standard Deviation 179 |
| Non-HLH Patients | Mean Serum Concentration of Alanine Aminotransferase | 34.0 IU/L | Standard Deviation 25.4 |
Primary
Mean Serum Concentration of Albumin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Albumin | 2.88 g/dL | Standard Deviation 0.6 |
| Non-HLH Patients | Mean Serum Concentration of Albumin | 3.48 g/dL | Standard Deviation 0.82 |
Primary
Mean Serum Concentration of Alkaline Phosphatase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Alkaline Phosphatase | 216.0 IU/L | Standard Deviation 170.5 |
| Non-HLH Patients | Mean Serum Concentration of Alkaline Phosphatase | 95.0 IU/L | Standard Deviation 74.5 |
Primary
Mean Serum Concentration of Aspartate Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Aspartate Aminotransferase | 177.8 international units/L (IU/L) | Standard Deviation 279.9 |
| Non-HLH Patients | Mean Serum Concentration of Aspartate Aminotransferase | 44.8 international units/L (IU/L) | Standard Deviation 18.4 |
Primary
Mean Serum Concentration of Basophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Basophils | 0.100 cells*10^3/mcL | Standard Deviation 0.087 |
| Non-HLH Patients | Mean Serum Concentration of Basophils | 0.820 cells*10^3/mcL | Standard Deviation 0.834 |
Primary
Mean Serum Concentration of Beta2-Microglobulin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Beta2-Microglobulin | 9.48 mg/L | Standard Deviation 15.19 |
| Non-HLH Patients | Mean Serum Concentration of Beta2-Microglobulin | 3.10 mg/L | — |
Primary
Mean Serum Concentration of Conjugated Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Conjugated Bilirubin | 1.96 mg/dL | Standard Deviation 3.71 |
| Non-HLH Patients | Mean Serum Concentration of Conjugated Bilirubin | 0.00 mg/dL | — |
Primary
Mean Serum Concentration of C-Reactive Protein
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of C-Reactive Protein | 102.508 mg/dL | Standard Deviation 174.824 |
Primary
Mean Serum Concentration of Creatinine
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Creatinine | 1.682 mg/dL | Standard Deviation 2.726 |
| Non-HLH Patients | Mean Serum Concentration of Creatinine | 0.808 mg/dL | Standard Deviation 0.287 |
Primary
Mean Serum Concentration of Eosinophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Eosinophils | 0.032 cells*10^3/mcL | Standard Deviation 0.044 |
| Non-HLH Patients | Mean Serum Concentration of Eosinophils | 1.083 cells*10^3/mcL | Standard Deviation 1.441 |
Primary
Mean Serum Concentration of Erythrocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Erythrocytes | 3.208 cells*10^12/L | Standard Deviation 0.371 |
| Non-HLH Patients | Mean Serum Concentration of Erythrocytes | 2.896 cells*10^12/L | Standard Deviation 0.543 |
Primary
Mean Serum Concentration of Fasting Triglycerides
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Fasting Triglycerides | 231.5 mg/dL | Standard Deviation 88.6 |
Primary
Mean Serum Concentration of Ferritin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Ferritin | 17240.3470 mcg/L | Standard Deviation 30134.8903 |
| Non-HLH Patients | Mean Serum Concentration of Ferritin | 3.8940 mcg/L | Standard Deviation 4.1748 |
Primary
Mean Serum Concentration of Hematocrit
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Hematocrit | 27.28 liter (L) of cells/L of blood | Standard Deviation 3.41 |
| Non-HLH Patients | Mean Serum Concentration of Hematocrit | 25.94 liter (L) of cells/L of blood | Standard Deviation 4.99 |
Primary
Mean Serum Concentration of Hemoglobin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Hemoglobin | 9.31 gram/deciliter (g/dL) | Standard Deviation 0.98 |
| Non-HLH Patients | Mean Serum Concentration of Hemoglobin | 8.52 gram/deciliter (g/dL) | Standard Deviation 1.95 |
Primary
Mean Serum Concentration of Immunoglobulin G (IgG)
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Immunoglobulin G (IgG) | 602.2 mg/dL | Standard Deviation 250.6 |
| Non-HLH Patients | Mean Serum Concentration of Immunoglobulin G (IgG) | 722.0 mg/dL | Standard Deviation 353.6 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | 5040.638 picogram/milliliter (pg/mL) | Standard Deviation 9622.745 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | 454.392 picogram/milliliter (pg/mL) | Standard Deviation 246.307 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | 8878.698 pg/mL | Standard Deviation 17582.571 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | 1864.255 pg/mL | Standard Deviation 4986.931 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | 279.951 pg/mL | Standard Deviation 898.74 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | 8.014 pg/mL | Standard Deviation 2.37 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | 46.562 pg/mL | Standard Deviation 124.537 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | 2.185 pg/mL | Standard Deviation 2.953 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | 2.140 pg/mL | Standard Deviation 0 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | 2.140 pg/mL | Standard Deviation 0 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | 597.385 pg/mL | Standard Deviation 1776.853 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | 10.059 pg/mL | Standard Deviation 28.771 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Neopterin | 257.120 nanomoles | Standard Deviation 223.475 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Neopterin | 51.909 nanomoles | Standard Deviation 47.869 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | 3796.175 nanogram/mL | Standard Deviation 3154.561 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | 1812.384 nanogram/mL | Standard Deviation 2852.523 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | 10183.509 pg/mL | Standard Deviation 12244.564 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | 2575.569 pg/mL | Standard Deviation 3395.536 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | 82.227 pg/mL | Standard Deviation 196.24 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | 417.603 pg/mL | Standard Deviation 1573.368 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | 12.412 pg/mL | Standard Deviation 14.899 |
| Non-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | 4.751 pg/mL | Standard Deviation 4.054 |
Primary
Mean Serum Concentration of Lactate Dehydrogenase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Lactate Dehydrogenase | 7469.5 IU/L | Standard Deviation 10456.7 |
| Non-HLH Patients | Mean Serum Concentration of Lactate Dehydrogenase | 1100.8 IU/L | Standard Deviation 718.5 |
Primary
Mean Serum Concentration of Leukocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Leukocytes | 2.11 cells*10^9/L | Standard Deviation 2.85 |
| Non-HLH Patients | Mean Serum Concentration of Leukocytes | 8.42 cells*10^9/L | Standard Deviation 8.94 |
Primary
Mean Serum Concentration of Lymphocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Lymphocytes | 0.468 cells*10^3/mcL | Standard Deviation 0.647 |
| Non-HLH Patients | Mean Serum Concentration of Lymphocytes | 0.968 cells*10^3/mcL | Standard Deviation 1.084 |
Primary
Mean Serum Concentration of Monocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Monocytes | 0.233 cells*10^3/mcL | Standard Deviation 0.272 |
| Non-HLH Patients | Mean Serum Concentration of Monocytes | 1.278 cells*10^3/mcL | Standard Deviation 1.034 |
Primary
Mean Serum Concentration of Natural Killer (NK) Cell Activity
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.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Natural Killer (NK) Cell Activity | 3.5 LU30 | Standard Deviation 0.7 |
Primary
Mean Serum Concentration of Neutrophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Neutrophils | 1.743 cells*10^3/microliter (mcL) | Standard Deviation 2.55 |
| Non-HLH Patients | Mean Serum Concentration of Neutrophils | 1.984 cells*10^3/microliter (mcL) | Standard Deviation 1.776 |
Primary
Mean Serum Concentration of Platelets
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Platelets | 43.9 cells*10^3/mcL | Standard Deviation 67.7 |
| Non-HLH Patients | Mean Serum Concentration of Platelets | 30.8 cells*10^3/mcL | Standard Deviation 38.5 |
Primary
Mean Serum Concentration of Sodium
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Sodium | 137.3 millimoles/L | Standard Deviation 7.4 |
| Non-HLH Patients | Mean Serum Concentration of Sodium | 139.5 millimoles/L | Standard Deviation 4.1 |
Primary
Mean Serum Concentration of Total Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Time frame: From Day 1 up to 39.5 months
Population: The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HLH Patients | Mean Serum Concentration of Total Bilirubin | 2.64 mg/dL | Standard Deviation 3.85 |
| Non-HLH Patients | Mean Serum Concentration of Total Bilirubin | 1.68 mg/dL | Standard Deviation 1.4 |