Prospective Cohort for Adult Hemophagocytosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hemophagocytic Lymphohistiocytoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Steroids

Intervention Type DRUG

High dose dexamethasone 20 mg PO or IV

Etoposide

Intervention Type DRUG

Etoposide 150mg/BSA

Interventions

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Steroids

High dose dexamethasone 20 mg PO or IV

Intervention Type DRUG

Etoposide

Etoposide 150mg/BSA

Intervention Type DRUG

Other Intervention Names

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Dexamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No