Prospective Cohort for Adult Hemophagocytosis

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Samsung Medical Center
Updated on 29 May 2022
immunosuppressive therapy


This prospective study enrolls subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis. The purpose of the study is to evaluate clinical and biological features of adult hemophagocytic lymphohistiocytosis. The enrolled subjects into this study will be evaluated according to the HLH (hemophagocytic lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or chemotherapy. All subjects will be regularly monitored by physicians participating in this study.


Study process is as follows.

  1. Informed consent for subjects fulfilling the inclusion criteria.
  2. Laboratory evaluation will be done for subjects according to the following diagnostic criteria.
    • Diagnosis will be established if one of either 1 or 2 below is fulfilled
  3. A molecular diagnosis consistent with HLH
  4. Diagnostic criteria for HLH fulfilled (5 out of 8 criteria below)
    • fever ≥ 38.5'C for ≥ 7 days
    • splenomegaly ≥ 3 finger breadth below left subcostal margin
    • cytopenias affecting ≥2 of 3 lineages in peripheral blood (Hemoglobin < 9 g/L, Platelets < 100 × 109/L, Absolute neutrophil count < 1.0 × 109/L)
    • Hypertriglyceridemia and/or hypofibrinogenemia: Fasting triglycerides ≥ 265 mg/dL, fibrinogen ≤ 1.5 g/L
    • Hemophagocytosis in bone marrow or spleen or lymph node
    • Low or absent NK-cell activity (according to local laboratory reference)
    • Ferritin ≥ 500 mcg/L
    • Soluble CD25 (sIL-2 receptor) ≥ 2,400 U/mL

Condition Hemophagocytic Lymphohistiocytoses
Treatment etoposide, Steroids
Clinical Study IdentifierNCT03117010
SponsorSamsung Medical Center
Last Modified on29 May 2022


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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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