Analyzing T-Cell Activation in Lymphoma Patients with HLH
Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
This study is trying to see if measuring T cell activity in patients newly diagnosed with aggressive lymphoma can help predict and improve the diagnosis of a serious condition called HLH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06585124 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between T cell activation and hemophagocytic lymphohistiocytosis (HLH) in patients newly diagnosed with aggressive lymphomas. It will involve the collection of peripheral blood samples for flow cytometric analysis to identify T-lymphocyte activation profiles and compare these with established diagnostic scores for HLH. The study seeks to predict the occurrence of lymphoma-associated HLH and identify new markers for early diagnosis, ultimately improving patient outcomes. A total of 150 patients will be enrolled within one year of their lymphoma diagnosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been newly diagnosed with aggressive lymphomas.
Not a fit: Patients with non-aggressive lymphomas or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of HLH in lymphoma patients, potentially improving survival rates.
How similar studies have performed: Previous studies have shown promise in using T-cell activation profiling for HLH diagnosis in pediatric populations, suggesting potential applicability in adult cases.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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) 3. Informed consent to the use of biologic materials for studies related to the present proposal. Exclusion Criteria: 1. Diagnosis of indolent non-Hodgkin's lymphoma or diagnoses other than those listed in the inclusion criteria 2. Prolonged steroid therapy, defined as lasting more than 15 days or high doses of steroid, exceeding 1 mg/kg 3. Age ≤ 18 years;
Where this trial is running
Rome, Lazio
- Stefan Hohaus — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Stefan Hohaus, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Stefan Hohaus, MD
- Email: stefan.hohaus@unicatt.it
- Phone: 063015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.