N/A
Completed N=40
Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
Source: ClinicalTrials.gov NCT03259230 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) — 5040.638; 454.392 picogram/milliliter (pg/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) |
5040.638; 454.392 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) |
8878.698; 1864.255 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) |
279.951; 8.014 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) |
46.562; 2.185 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) |
2.140; 2.140 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) |
597.385; 10.059 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Neopterin |
257.120; 51.909 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) |
12.412; 4.751 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) |
82.227; 417.603 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) |
3796.175; 1812.384 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) |
10183.509; 2575.569 | — |
| PRIMARY Mean Serum Concentration of Hemoglobin |
9.31; 8.52 | — |
| PRIMARY Mean Serum Concentration of Hematocrit |
27.28; 25.94 | — |
| PRIMARY Mean Serum Concentration of Erythrocytes |
3.208; 2.896 | — |
| PRIMARY Mean Serum Concentration of Leukocytes |
2.11; 8.42 | — |
| PRIMARY Mean Serum Concentration of Neutrophils |
1.743; 1.984 | — |
| PRIMARY Mean Serum Concentration of Lymphocytes |
0.468; 0.968 | — |
| PRIMARY Mean Serum Concentration of Monocytes |
0.233; 1.278 | — |
| PRIMARY Mean Serum Concentration of Eosinophils |
0.032; 1.083 | — |
| PRIMARY Mean Serum Concentration of Basophils |
0.100; 0.820 | — |
| PRIMARY Mean Serum Concentration of Platelets |
43.9; 30.8 | — |
| PRIMARY Mean Plasma Concentration of Fibrinogen |
207.5; 357.5 | — |
| PRIMARY Mean Plasma Concentration of D-Dimer |
10.165; 2.220 | — |
| PRIMARY Mean Serum Concentration of Ferritin |
17240.3470; 3.8940 | — |
| PRIMARY Mean Serum Concentration of Fasting Triglycerides |
231.5 | — |
| PRIMARY Mean Serum Concentration of Creatinine |
1.682; 0.808 | — |
| PRIMARY Mean Plasma Concentration of Blood Urea Nitrogen |
44.68; 29.00 | — |
| PRIMARY Mean Serum Concentration of Albumin |
2.88; 3.48 | — |
| PRIMARY Mean Serum Concentration of Sodium |
137.3; 139.5 | — |
| PRIMARY Mean Serum Concentration of Beta2-Microglobulin |
9.48; 3.10 | — |
| PRIMARY Mean Serum Concentration of Immunoglobulin G (IgG) |
602.2; 722.0 | — |
| PRIMARY Mean Serum Concentration of C-Reactive Protein |
102.508 | — |
| PRIMARY Mean Serum Concentration of Aspartate Aminotransferase |
177.8; 44.8 | — |
| PRIMARY Mean Serum Concentration of Alanine Aminotransferase |
127.9; 34.0 | — |
| PRIMARY Mean Serum Concentration of Alkaline Phosphatase |
216.0; 95.0 | — |
| PRIMARY Mean Serum Concentration of Lactate Dehydrogenase |
7469.5; 1100.8 | — |
| PRIMARY Mean Serum Concentration of Total Bilirubin |
2.64; 1.68 | — |
| PRIMARY Mean Serum Concentration of Conjugated Bilirubin |
1.96; 0.00 | — |
| PRIMARY Mean Serum Concentration of Natural Killer (NK) Cell Activity |
3.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
N/A
Data sourced from ClinicalTrials.gov (NCT03259230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.