Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas

Last updated: September 3, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Treatment

Flow Cytometry

Clinical Study ID

NCT06585124
ID-6536
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Age > 18 years

  2. Diagnosis at onset of aggressive lymphoma including the following histotypes:

  • 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 gradeB-cell lymphoma with MYC and BCL2 rearrangement ALK-positive large B-celllymphoma; Large B-cell lymphoma with IRF4 rearrangement; High grade B-celllymphoma with 11q alterations; Lymphomatoid granulomatosis; EBV-positive largeB-cell lymphoma Large B-cell lymphoma associated with chronic inflammation;Fibrin-associated large B-cell lymphoma; Fluid overload-associated large B-celllymphoma; Plasmoblastic lymphoma; Immune-privileged site B-cell lymphomaPrimary cutaneous leg-type large B-cell lymphoma; Intravascular large B-celllymphoma; Primary mediastinal large B-cell lymphoma; Mediastinal grey zonelymphoma; High grade NOS B-cell lymphoma)

  • Burkitt lymphoma

  • KSHV/HHV8 a ssociatedlymphomas

  • Lymphomas associated with immunodeficiency or immune dysregulation

  • Mature T-cell-derived lymphomas (NOS peripheral T-cell lymphoma; Nodalfollicular helper T-cell lymphoma; Anaplastic large cell lymphoma; Nodal andextranodal EBV-positive T/NK-cell lymphomas; Hepatosplenic T-cell lymphoma;Enteropathy-associated intestinal T-cell lymphoma, epitheliotropic monomorphicand NOS; Subcutaneous T-cell lymphoma similar to panniculitis)

  1. Informed consent to the use of biologic materials for studies related to the presentproposal.

Exclusion

Exclusion Criteria:

  1. Diagnosis of indolent non-Hodgkin's lymphoma or diagnoses other than those listed inthe inclusion criteria

  2. Prolonged steroid therapy, defined as lasting more than 15 days or high doses ofsteroid, exceeding 1 mg/kg

  3. Age ≤ 18 years;

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Flow Cytometry
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
May 01, 2026

Study Description

Hemophagocytic lymphohistiocytosis (HLH) is a rare and severe syndrome characterized by excessive immune system activation and dysregulation. This leads to an overproduction of cytokines and activation of the histiocytic-macrophage system, potentially resulting in multi-organ failure and death. HLH can be classified into primary and secondary forms. Secondary HLH is often triggered by infections, autoimmune diseases, or neoplasms, with lymphomas being the most frequent neoplastic triggers.

There is limited knowledge about secondary HLH, particularly regarding early diagnosis and optimal management. This project aims to address this gap by analyzing cytotoxic T-cells and cell expression markers using flow cytometry, building on findings from two pediatric studies.

Aggressive onset lymphomas may induce a systemic hyperinflammatory state, complicating the diagnosis of HLH, especially in the presence of concurrent bacterial or viral infections. Given the rarity of HLH and its poor prognosis if not promptly diagnosed, further research is crucial, especially in lymphoma-associated cases.

This study aims to apply T-cell activation profiling, previously demonstrated in pediatric populations, to patients with aggressive Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma to identify HLH-associated cases at onset.

The study aims to include 150 patients diagnosed with aggressive lymphoma within a one-year period A peripheral blood sample, collected alongside routine blood chemistry tests at diagnosis, will be used for the flow cytometric study of the T-lymphocyte activation profile. Data pertaining to disease characteristics will be gathered to calculate diagnostic scores for HLH, including the H-score, HLH-2004 score, and OHI score. The flow cytometry results will then be compared with these score parameters to assess their correlation with the diagnosis of lymphoma-associated HLH (LA-HLH).

Connect with a study center

  • Stefan Hohaus

    Rome, Lazio 00168
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.