About this trial
The goal of this study is to explore the associations between T cell activation and the occurrence of hemophagocytic lymphohistiocytosis (HLH) in patients with newly diagnosed lymphomas. The specific aims are:
Prediction of Lymphoma-Associated HLH (LA-HLH): Compare flow cytometric T cell activation markers with the H-score to predict LA-HLH.
Identification of new markers for predicting HLH in patients with aggressive lymphoma.
Description of the incidence rate of LA-HLH. Assessment of the outcomes of LA-HLH identified by flow cytometric analysis or the H-score.
This prospective, single-center observational study will include 150 patients newly diagnosed with aggressive lymphoma within one year. Peripheral blood samples will be taken at diagnosis alongside routine blood chemistry tests for flow cytometric analysis of the T-lymphocyte activation profile. Data on disease characteristics will be collected to calculate the H-score, HLH-2004 score, and OHI score for diagnosing HLH. The flow cytometry results will be compared with these scores to evaluate their effectiveness in diagnosing LA-HLH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Hodgkin lymphoma
Transformed B cell lymphomas;
Diffuse large B-cell lymphomas (diffuse large B-cell lymphoma NOS; T-cell/histiocyte-rich B-cell lymphoma; High grade B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangement ALK-positive large B-cell lymphoma; Large B-cell lymphoma with IRF4 rearrangement; High grade B-cell lymphoma with 11q alterations; Lymphomatoid granulomatosis; EBV-positive large B-cell lymphoma Large B-cell lymphoma associated with chronic inflammation; Fibrin-associated large B-cell lymphoma; Fluid overload-associated large B-cell lymphoma; Plasmoblastic lymphoma; Immune-privileged site B-cell lymphoma Primary cutaneous leg-type large B-cell lymphoma; Intravascular large B-cell lymphoma; Primary mediastinal large B-cell lymphoma; Mediastinal grey zone lymphoma; High grade NOS B-cell lymphoma)
Disqualifiers
Diagnosis of indolent non-Hodgkin's lymphoma or diagnoses other than those listed in the inclusion criteria
Prolonged steroid therapy, defined as lasting more than 15 days or high doses of steroid, exceeding 1 mg/kg
Age ≤ 18 years;
Trial population
adult patients with newly diagnosed lymphomas
Trial design
Cohort
Other
Treatments tested in this trial
Flow Cytometry
Diagnostic testStudy of t cell population in flow cytometry
Treatment groups
Trial outcomes
Primary outcomes
Assocation of flow cytometry parameters on peripheral blood with the H-score, the standard for the diagnosis of lymphoma-associated HLH
Diagnostic rate of flow cytometry for lymphoma-associated HLH
Secondary outcomes
Determine the incidence of LA-HLH
incidence rate
To evaluate the outcome of patients with LA-HLH
overall survival
Define the rate of complete responses to lymphoma treatment
Complete remission rate
Sponsors and contacts
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