Hemophagocytic LymphohistiocytosesNCT03117010
Prospective Cohort for Adult Hemophagocytosis
An observational study of Hemophagocytic Lymphohistiocytoses, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytoses
- What is being tested?
- Steroids and Etoposide
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis.
Who may be able to join
- 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
Who cannot join
- Subjects cannot satisfy the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Seok Jin Kim, MD, PhD, 82-2-3410-1766, kstwoh@skku.edu
Seok Jin Kim, MD, PhD
About this study
Official title: A Prospective Cohort for Subjects With Adult Hemophagocytic Lymphohistiocytosis Like Syndrome
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.
- 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
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Being tested
- Steroids, Etoposide
- Keywords
- Hemophagocytic lymphohistiocytosis
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidsDrug
Also called Dexamethasone
High dose dexamethasone 20 mg PO or IV
EtoposideDrug
Etoposide 150mg/BSA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Steroids; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Response to steroids and etoposide
Measured: 28 days after the 1st treatment
Secondary outcomes (2)
Progression-free survival
Time to date of progression or any kinds of death
Measured: 3 years
Overall survival
Time to date of any kinds of death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophagocytic LymphohistiocytosesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Jin Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117010
- Sponsor's protocol ID
- 2016-08-117
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort for Subjects With Adult Hemophagocytic Lymphohistiocytosis Like Syndrome
- ClinicalTrials.gov ID
- NCT03117010
- Acronym / sponsor ID
- 2016-08-117
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Keywords
- Hemophagocytic lymphohistiocytosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophagocytosis | – | Drug: Steroids, Drug: EtoposideSubjects 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis.
Key inclusion criteria (6 listed)
- Subjects should fulfill the following criteria
Key exclusion criteria (1 listed)
- Subjects cannot satisfy the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteroidsAlso: DexamethasoneHigh dose dexamethasone 20 mg PO or IV | Drug | Hemophagocytosis |
| EtoposideEtoposide 150mg/BSA | Drug | Hemophagocytosis |
Primary outcome
Response
Time frame: 28 days after the 1st treatment
Response to steroids and etoposide
2 secondary outcomes
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 32440790Yoon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seok Jin Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytoses, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seok Jin Kim, MD, PhD (+82234101766, kstwoh@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 28 days after the 1st treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.