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

NCT06585124 | Recruiting

• 1 other identifier: ID-6536
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma; Hemophagocytic Lymphohistiocytoses

Keywords

Flow Cytometry; T cell activation; lymphoma; HLH

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (3)

• Determine the incidence of LA-HLH

  2 years

• To evaluate the outcome of patients with LA-HLH

  2 years

• Define the rate of complete responses to lymphoma treatment

  2 years

Interventions

Flow Cytometry DIAGNOSTIC_TEST

Study of t cell population in flow cytometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with newly diagnosed lymphomas

You may qualify if:

• Age \> 18 years
• 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 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)
• Burkitt lymphoma
• KSHV/HHV8 a ssociatedlymphomas
• Lymphomas associated with immunodeficiency or immune dysregulation
• Mature T-cell-derived lymphomas (NOS peripheral T-cell lymphoma; Nodal follicular helper T-cell lymphoma; Anaplastic large cell lymphoma; Nodal and extranodal EBV-positive T/NK-cell lymphomas; Hepatosplenic T-cell lymphoma; Enteropathy-associated intestinal T-cell lymphoma, epitheliotropic monomorphic and NOS; Subcutaneous T-cell lymphoma similar to panniculitis)
• Informed consent to the use of biologic materials for studies related to the present proposal.

You may not qualify if:

• Prolonged steroid therapy, defined as lasting more than 15 days or high doses of steroid, exceeding 1 mg/kg
• Age ≤ 18 years;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Stefan Hohaus

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphohistiocytosis, Hemophagocytic

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stefan Hohaus, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Hohaus, MD

CONTACT

063015; stefan.hohaus@unicatt.it

Flaminia Bellisario, MD

CONTACT

063015; flaminia.bellisario@guest.policlinicogemell.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-07

Locations

IT (1)