Prospective Cohort for Adult Hemophagocytosis
ConditionHemophagocytic Lymphohistiocytoses
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subjects cannot satisfy the inclusion criteria
Trial population
Subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Steroids
DrugHigh dose dexamethasone 20 mg PO or IV
Etoposide
DrugEtoposide 150mg/BSA
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: Hemophagocytosis2 interventions
Trial outcomes
Primary outcomes
1
Response
Response to steroids and etoposide
Time frame
28 days after the 1st treatmentSecondary outcomes
1
Progression-free survival
Time to date of progression or any kinds of death
Time frame
3 years2
Overall survival
Time to date of any kinds of death
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov