NCT03117010

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2017Dec 2028

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

12 years

First QC Date

April 12, 2017

Last Update Submit

April 23, 2026

Conditions

Keywords

Hemophagocytic lymphohistiocytosis

Outcome Measures

Primary Outcomes (1)

  • Response

    Response to steroids and etoposide

    28 days after the 1st treatment

Secondary Outcomes (2)

  • Progression-free survival

    3 years

  • Overall survival

    3 years

Study Arms (1)

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: SteroidsDrug: Etoposide

Interventions

High dose dexamethasone 20 mg PO or IV

Also known as: Dexamethasone
Hemophagocytosis

Etoposide 150mg/BSA

Hemophagocytosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

1. Serum sample collection will be done as follows: Baseline, 4 weeks after treatment, Relapse or progression 2. Germline DNA collection from peripheral blood will be done at the enrollment

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

SteroidsDexamethasoneEtoposide

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Seok Jin Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Jin Kim, MD, PhD

CONTACT

Silvia Park, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 17, 2017

Study Start

January 1, 2017

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations