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RecruitingNCT03117010Updated Apr 24, 2026

Prospective Cohort for Adult Hemophagocytosis

An observational study in Hemophagocytic Lymphohistiocytoses, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
81
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

      1. A molecular diagnosis consistent with HLH
      2. 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
02

Conditions studied

  • Hemophagocytic Lymphohistiocytoses

Keywords

  • Hemophagocytic lymphohistiocytosis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis.

Inclusion criteria

  • Subjects should fulfill the following criteria

    1. Subjects should have at least one of the following problems

      1. Presence of hemophagocytosis in tissue or bone marrow
      2. Presence of at least 3 conditions among 8 conditions of HLH diagnostic criteria
    2. Age > 18 years
    3. Written informed consents

Exclusion criteria

Exclusion Criteria:

  • Subjects cannot satisfy the inclusion criteria
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
81 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Hemophagocytosis

    Subjects should fulfill the following criteria 1. Subjects should have at least one of the following problems 1. Presence of hemophagocytosis in tissue or bone marrow 2. Presence of at least 3 conditions among 8 conditions of HLH diagnostic criteria 2. Age \> 18 years 3. Written informed consents Subjects receive steroids and etoposide

    Drug: Steroids · Drug: Etoposide

Interventions

  • DrugSteroids

    High dose dexamethasone 20 mg PO or IV

    Also known as: Dexamethasone

  • DrugEtoposide

    Etoposide 150mg/BSA

05

What researchers measure

Primary outcomes

  1. Response

    Response to steroids and etoposide

    Time frame: 28 days after the 1st treatment

Secondary outcomes

  1. Progression-free survival

    Time to date of progression or any kinds of death

    Time frame: 3 years

  2. Overall survival

    Time to date of any kinds of death

    Time frame: 3 years

06

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, South Korea
    • Seok Jin Kim, MD, PhD · Contact · kstwoh@skku.edu · 82-2-3410-1766
    • Seok Jin Kim, MD, PhD · Principal investigator
    • Won Seog Kim, MD, PhD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Yoon SE, Eun Y, Huh K, Chung CR, Yoo IY, Cho J, Cho D, Ko YH, Park S, Kim WS, Kim SJ. A comprehensive analysis of adult patients with secondary hemophagocytic lymphohistiocytosis: a prospective cohort study. Ann Hematol. 2020 Sep;99(9):2095-2104. doi: 10.1007/s00277-020-04083-6. Epub 2020 May 21. PubMed 32440790 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03117010
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Apr 17, 2017
Start date
Jan 1, 2017
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 24, 2026

Study contacts

Seok Jin Kim, MD, PhD
Contact
kstwoh@skku.edu
+82234101766
Silvia Park, MD, PhD
Contact
silvia.park@samsung.com
+82234103459
Seok Jin Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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