ClinicalTrials.gov record NCT03117010
Prospective Cohort for Adult Hemophagocytosis
A Prospective Cohort for Subjects With Adult Hemophagocytic Lymphohistiocytosis Like Syndrome
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study enrolls adults with clinical and laboratory signs of hemophagocytic lymphohistiocytosis (HLH). Participants are evaluated using HLH diagnostic criteria and, according to their treating physicians, may receive systemic immunosuppressive therapy or chemotherapy (steroids and etoposide) while being regularly monitored. The study collects clinical and biological data and follows participants for up to three years.
What it is studying. The study is collecting clinical and biological information to describe features of adult HLH. It records diagnostic findings, treatments given (including steroids and etoposide), short-term treatment response at 28 days, and longer-term outcomes including progression-free and overall survival over three years.
What the researchers hope to learn. To evaluate and describe clinical and biological features of adult HLH; to measure response to steroids and etoposide at 28 days; and to document progression-free survival and overall survival over three years.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Steroids
- Etoposide
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Subjects should fulfill the following criteria
- Subjects should have at least one of the following problems
- Presence of hemophagocytosis in tissue or bone marrow
- Presence of at least 3 conditions among 8 conditions of HLH diagnostic criteria
- Age > 18 years
- Written informed consents
Exclusion criteria
- Subjects cannot satisfy the inclusion criteria
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Study process is as follows.
- Informed consent for subjects fulfilling the inclusion criteria.
- 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
- A molecular diagnosis consistent with HLH
- 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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you join, you will sign informed consent and have diagnostic laboratory evaluations for HLH. You may undergo tissue sampling such as a bone-marrow biopsy (or review of existing tissue) to look for hemophagocytosis. Treating physicians will monitor you and may give systemic treatments recorded in the study (the record lists high‑dose dexamethasone and etoposide); your medical care and response will be followed, with a response assessment about 28 days after first treatment and follow-up for outcomes over about 3 years.
How the study is structured. A prospective observational cohort: adults with HLH-related clinical or laboratory findings are enrolled, assessed according to HLH criteria, treated as decided by their doctors (steroids and etoposide are used in the cohort), and followed with regular monitoring and data collection for up to three years. There is no random assignment to treatments.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hemophagocytic lymphohistiocytosis
Important dates
- Study start
- Jan 1, 2017
- Primary completion
- Dec 31, 2028 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 81 participants (estimated)
- Last updated on registry
- Apr 24, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Samsung Medical Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Seok Jin Kim, MD, PhD 📞 +82234101766 ✉ kstwoh@skku.edu
- Silvia Park, MD, PhD 📞 +82234103459 ✉ silvia.park@samsung.com
Participating sites (1)
- Samsung Medical CenterRecruiting
Seoul, 135-710 · South Korea
- Seok Jin Kim, MD, PhD · 82-2-3410-1766 · kstwoh@skku.edu
- Seok Jin Kim, MD, PhD
- Won Seog Kim, MD, PhD
Terms used on this page · explanations by MedicalUpdates.ai
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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