An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点