LymphomaLA-HLHNCT06585124
Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas
An observational study of Lymphoma and Hemophagocytic Lymphohistiocytoses, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- What is being tested?
- Flow Cytometry
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with newly diagnosed lymphomas
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Stefan Hohaus
Rome, Lazio, 00168
Stefan Hohaus, MD, 063015 ext. 4180, stefan.hohaus@unicatt.it
Flaminia Bellisario, MD, 063015 ext. 4180, flaminia.bellisario@guest.policlinicogemelli.it
About this study
Official title: Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
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.
Read more
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.
Read the detailed 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).
- Conditions
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- Being tested
- Flow Cytometry
- Keywords
- Flow Cytometry, T cell activation, lymphoma, HLH
- Medical subject headings
- Lymphoma, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow CytometryDiagnostic test
Study of t cell population in flow cytometry
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Determine the incidence of LA-HLH
incidence rate
Measured: 2 years
To evaluate the outcome of patients with LA-HLH
overall survival
Measured: 2 years
Define the rate of complete responses to lymphoma treatment
Complete remission rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Hohaus, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585124
- Sponsor's protocol ID
- ID-6536
- Acronym
- LA-HLH
- Status last verified
- Jul 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision on IPD will be jointly made by investigators at end of study
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Application of Flow Cytometry for the Study of T-Cell Populations in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT06585124
- Acronym / sponsor ID
- LA-HLH / ID-6536
- Conditions
- Lymphoma, Hemophagocytic Lymphohistiocytoses
- Keywords
- Flow Cytometry, T cell activation, lymphoma, HLH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with newly diagnosed lymphomas
Key inclusion criteria (10 listed)
- Age > 18 years
- Diagnosis at onset of aggressive lymphoma including the following histotypes:
- Informed consent to the use of biologic materials for studies related to the present proposal.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow CytometryStudy of t cell population in flow cytometry | Diagnostic test | – |
Primary outcome
Assocation of flow cytometry parameters on peripheral blood with the H-score, the standard for the diagnosis of lymphoma-associated HLH
Time frame: 2 years
Diagnostic rate of flow cytometry for lymphoma-associated HLH
3 secondary outcomes
Determine the incidence of LA-HLH
Time frame: 2 years
To evaluate the outcome of patients with LA-HLH
Time frame: 2 years
Define the rate of complete responses to lymphoma treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided. Decision on IPD will be jointly made by investigators at end of study
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Hohaus, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Hemophagocytic Lymphohistiocytoses, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Hohaus, MD (063015 ext. 4180, stefan.hohaus@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assocation of flow cytometry parameters on peripheral blood with the H-score, the standard for the diagnosis of lymphoma-associated HLH (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.