AzTrials
AzTrials

Classical Hodgkin LymphomaLH_BIONCT06822855

Changing Paragidms In The Prognostic Assessment Of Hodgkin Lymphoma

An observational study of Classical Hodgkin Lymphoma and Classical Hodgkin Lymphoma Recurrent, run by Azienda USL Reggio Emilia - IRCCS at 12 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Classical Hodgkin's Lymphoma (cHL) is a rare but highly treatable malignancy of the immune system, primarily affecting young adults. Despite significant therapeutic advancements, frontline treatment failure occurs in up to 30% of cases, with relapse or refractory disease affecting over 50% of these patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
755 participants
Where
12 sitesItaly
Study dates
23 Jun 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study will involve three patient cohorts, with participants recruited from multiple centers across Italy during routine follow-up visits. Cohort A will include 70 patients with classical Hodgkin lymphoma (cHL) who have a histological confirmation of relapse or progression. These patients will be enrolled at the time of disease relapse/progression, and plasma samples for ctDNA analysis will be collected concurrently. Cohort B will consist of 200 cHL patients who have completed active treatment and entered the follow-up phase. Plasma samples will be collected from these patients at the time of enrollment (P0) and again at a six-month follow-up (P6FU). This cohort will be followed for a minimum of two years from the time of enrollment. Cohort C is a retrospective cohort that will be divided into two subgroups: Training cohort: 235 consecutive cHL patients collected from the archives of the Hematology Unit of AUSL-IRCCS between 2004 and 2019. This cohort is representative of the ge

Who may be able to join

  • Age >18 anni
  • Written informed consent signed
  • Cohort A
  • Age >18 years
  • Histologically confirmed diagnosis of relapsed/refractory classical Hodgkin lymphoma identified during induction or follow-up
  • Available formalin-fixed, paraffin-embedded (FFPE) biopsy at diagnosis and at the time of progression/relapse
Show all 23Show fewer
  • Available plasma sample at progression (before the beginning of salvage therapy)
  • Available FDG-PET evaluation at study enrollment
  • Available clinical, laboratory, and radiologic data at diagnosis and relapse
  • Cohort B
  • Diagnosis of classical Hodgkin lymphoma
  • Completion of first-line standard systemic treatment (chemotherapy-based or chemoradiotherapy combined modality)
  • Available plasma sample at the end of treatment (at least 30 days from the last chemotherapy)
  • Available FFPE biopsy at diagnosis
  • No further treatment planned
  • Available clinical, laboratory, and radiologic data at diagnosis and response evaluation
  • Patient's willingness to undergo 6 months follow-up plasma sample collection and to attend regular follow-up
  • Cohort C
  • Histologically confirmed diagnosis of classical Hodgkin lymphoma
  • Standard treatment as per available guidelines (e.g., ESMO guidelines)
  • Available treatment data, response, and follow-up data
  • Available FFPE biopsy at diagnosis
  • Available FDG-PET evaluation at study enrollment

Who cannot join

  • Patients with nodular lymphocyte predominant Hodgkin lymphoma are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte-rich, and mixed cellularity Hodgkin lymphoma may be enrolled.
  • Active HIV, HBV, HCV viral infection
  • Concomitant neoplasm not treated with a curative aim

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Attilio Gennaro, Clinical Research Coordinator contact

+39 0522 295175

attilio.gennaro@ausl.re.it

12 sites in 1 country

Italy12 sites, 12 recruiting

  • A.O.S.G. Moscati

    Avellino

    Sonya De Lorenzo, MD, sonya.delorenzo@tin.it

    Sonya De Lorenzo, MD

    Recruiting

  • Spedali Civili Brescia

    Brescia

    Alessandro Re, MD, alessandro.re@asst-spedalicivili.it

    Alessandro Re, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Vittorio Ruggero Zilioli, MD, 02 6444.2668, vittorioruggero.zilioli@ospedaleniguarda.it

    Vittorio Ruggero Zilioli, MD

    Recruiting

  • Istituto Oncologico Veneto

    Padova

    Dario Marino, MD, dario.marino@iov.veneto.it

    Dario Marino, MD

    Recruiting

  • Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

    Palermo

    caterina Patti, MD, k.patti@villasofia.it

    Caterina Patti, MD

    Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia

    Leonardo Flenghi, MD, leonardo.flenghi@ospedale.perugia.it

    Leonardo Flenghi, MD

    Recruiting

  • Ospedale S. Maria della Misericordia, Azienda Ospedaliera di Perugia

    Perugia

    Eleonora Lusenti, Clinical Research Coordinator, eleo95@gmail.com

    Gaetano Vaudo, MD

    Recruiting

  • AUSL Piacenza

    Piacenza

    Annalisa Arcari Arcari, MD, a.arcari@ausl.pc.it

    Annalisa Arcari, MD

    Recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, RE, 42123

    Attilio Gennaro, Clinical Research Coordinator, +39 0522 295175, attilio.gennaro@ausl.re.it

    Stefano Luminari, MD

    Recruiting

  • Azienda Ospedaliera Santa Maria - Terni

    Terni, 05100

    Recruiting

  • AOU Città della salute e della Scienza, "Le Molinette"

    Torino

    Candida Vitale, MD, candida.vitale@unito.it

    candida Vitale, MD

    Recruiting

  • AOU Città della Salute e della Scienza

    Torino

    Barbara Botto, MD, bbotto@cittadellasalute.to.it

    Barbara Botto, MD

    Recruiting

Other trials in Italy

About this study

Classical Hodgkin's Lymphoma (cHL) is a rare but highly treatable malignancy of the immune system, primarily affecting young adults. Despite significant therapeutic advancements, frontline treatment failure occurs in up to 30% of cases, with relapse or refractory disease affecting over 50% of these patients. The main therapeutic challenge in cHL remains achieving an optimal balance between disease control and reducing long-term adverse effects. Current prognostic tools only partially capture patient heterogeneity, and cHL continues to evolve spatially and temporally throughout the course of the disease. Personalized treatment strategies require novel integrated tools that better monitor tumor complexity and anticipate disease progression.

Fluorodeoxyglucose positron emission tomography (FDG-PET) has improved risk stratification in cHL, as metabolic response during or after chemotherapy strongly correlates with disease progression and survival. However, FDG-PET has limitations, including the absence of standardized criteria and the necessity to initiate treatment before response assessment. To overcome these limitations, molecular profiling and radiomic analysis of baseline FDG-PET data may provide deeper insights into tumor biology, improving prognostic accuracy.

Read more

This observational study aims to dissect the genetic and phenotypic heterogeneity of cHL at diagnosis and during disease evolution, with the goal of identifying novel prognostic biomarkers. These findings could lead to better treatment personalization, increasing cure rates while minimizing treatment-related toxicity. The study is based on the hypothesis that correlating DNA profiling at diagnosis, gene expression, and radiomic features may enable the identification of high-risk signatures, refining prognostic models in cHL. Additionally, liquid biopsy represents a non-invasive method for assessing tumor mutational complexity. The analysis of circulating DNA (cDNA) throughout disease progression could provide insights into genetic evolution and help predict overt progression before clinical manifestations occur.

The primary objective is to define the genetic mutational profile of cHL at disease progression. As secondary objectives, it will evaluate whether liquid biopsy can accurately recapitulate the genetic heterogeneity observed in tumor tissue, determine the predictive accuracy of liquid biopsy in anticipating disease progression, and correlate genomic and radiomic features with patient outcomes to refine risk stratification and therapeutic decision-making.

By integrating molecular and imaging-based biomarkers, this study aims to enhance personalized treatment strategies, improve risk-adapted therapeutic approaches, and ultimately optimize curability and quality of life for patients with cHL.

Read the detailed description

This study has both retrospective and prospective components. The prospective part includes patients with Classical Hodgkin's Lymphoma (cHL) who have completed active treatment and entered follow-up (Cohort A), as well as patients with a histological confirmation of relapse or progression (Cohort B). The retrospective cohort (Cohort C) consists of 235 consecutive cHL patients collected from the archives of the Hematology Unit of AUSL-IRCCS between 2004 and 2019, along with up to 250 cHL patients diagnosed between 2016 and 2021 from other Italian hematology centers.

Keywords
Liquid Biopsy, classical Hodgkin Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06822855
Study groupRoleWhat they receive
Post-Treatment Follow-Up Cohort (Cohort A)cHL patients who have completed active treatment and entered follow-up.
Relapsed/Progressive Disease Cohort (Cohort B)cHL patients with a histological confirmation of relapse or disease progression.
Retrospective cHL Cohort (Cohort C)Consecutive cHL patients from the archives of the Hematology Unit of AUSL-IRCCS, diagnosed between 2004 and 2019 and 250 cHL patients diagnosed between 2016 and 2021 from other Italian hematology centers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic Mutational Profiling of cHL at Progression

    The mutational profile of Classical Hodgkin's Lymphoma patients enrolled in Cohort A will be generated using deep sequencing technologies, including Cancer Personalized Profiling by deep-sequencing (CAPP-seq), on biopsy samples collected at the time of initial diagnosis and at the time of progression to identify key alterations associated with disease progression and aggressiveness.

    Measured: At enrollement

Secondary outcomes (4)

  1. Liquid Biopsy Ability to Recapitulate Tissue Genetic Heterogeneity

    Circulating tumor DNA (ctDNA) from plasma samples collected at baseline (Cohort B) and at the time of disease progression (Cohorts A and B) will be analyzed using CAPP-seq and compared with matched germline DNA (gDNA). Identified mutations will be compared to a background variant database to filter out technical sequencing errors and identify true positive alterations. Heatmaps and COSMIC database annotations will be used to assess the functional relevance of selected variants. The mutational profile in plasma will be compared with biopsy results obtained at progression to evaluate the ability of ctDNA to capture tumor heterogeneity and progression-related alterations.

    Measured: Up to 4 years

  2. Accuracy of Liquid Biopsy in Anticipating Disease Progression

    Plasma samples of Cohort B patients will be collected at enrollement and at 6 months of follow-up, and the presence of mutations will be assessed using deep sequencing (CAPP-seq). The results will be compared with clinical outcomes over a follow-up period of at least 2 years to determine the specificity and sensitivity of liquid biopsy in predicting progression.

    Measured: From 2 up to 4 years

  3. Correlation between Gene Expression Profiling and Progression-free survival (PFS)

    Gene expression profiling conducted on tissue samples from subjects in Cohort C at diagnosis will be correlated with progression-free survival (PFS).

    Measured: Up to 4 years

  4. Correlation between Gene Expression Profiling and cnical events like relapse and refractoriness

    Gene expression profiling conducted on tissue samples from subjects in Cohort C at diagnosis will be correlated with cnical events like relapse and refractoriness).

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start23 Jun 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
755 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06822855
Sponsor's protocol ID
696/2021/TESS/IRCCSRE
Acronym
LH_BIO
Status last verified
May 2026
First submitted
7 Feb 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Merli F, Luminari S, Gobbi PG, Cascavilla N, Mammi C, Ilariucci F, Stelitano C, Musso M, Baldini L, Galimberti S, Angrilli F, Polimeno G, Scalzulli PR, Ferrari A, Marcheselli L, Federico M. Long-Term Results of the HD2000 Trial Comparing ABVD Versus BEACOPP Versus COPP-EBV-CAD in Untreated Patients With Advanced Hodgkin Lymphoma: A Study by Fondazione Italiana Linfomi. J Clin Oncol. 2016 Apr 10;34(11):1175-81. doi: 10.1200/JCO.2015.62.4817. Epub 2015 Dec 28.

    PubMed 26712220

  • Andre MPE, Girinsky T, Federico M, Reman O, Fortpied C, Gotti M, Casasnovas O, Brice P, van der Maazen R, Re A, Edeline V, Ferme C, van Imhoff G, Merli F, Bouabdallah R, Sebban C, Specht L, Stamatoullas A, Delarue R, Fiaccadori V, Bellei M, Raveloarivahy T, Versari A, Hutchings M, Meignan M, Raemaekers J. Early Positron Emission Tomography Response-Adapted Treatment in Stage I and II Hodgkin Lymphoma: Final Results of the Randomized EORTC/LYSA/FIL H10 Trial. J Clin Oncol. 2017 Jun 1;35(16):1786-1794. doi: 10.1200/JCO.2016.68.6394. Epub 2017 Mar 14.

    PubMed 28291393

  • Eichenauer DA, Aleman BMP, Andre M, Federico M, Hutchings M, Illidge T, Engert A, Ladetto M; ESMO Guidelines Committee. Hodgkin lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv19-iv29. doi: 10.1093/annonc/mdy080. No abstract available.

    PubMed 29796651

  • Hoppe RT, Advani RH, Ai WZ, Ambinder RF, Aoun P, Armand P, Bello CM, Benitez CM, Bierman PJ, Chen R, Dabaja B, Dean R, Forero A, Gordon LI, Hernandez-Ilizaliturri FJ, Hochberg EP, Huang J, Johnston PB, Kaminski MS, Kenkre VP, Khan N, Maddocks K, Maloney DG, Metzger M, Moore JO, Morgan D, Moskowitz CH, Mulroney C, Rabinovitch R, Seropian S, Tao R, Winter JN, Yahalom J, Burns JL, Ogba N. NCCN Guidelines Insights: Hodgkin Lymphoma, Version 1.2018. J Natl Compr Canc Netw. 2018 Mar;16(3):245-254. doi: 10.6004/jnccn.2018.0013.

    PubMed 29523663

  • Luminari S, Donati B, Casali M, Valli R, Santi R, Puccini B, Kovalchuk S, Ruffini A, Fama A, Berti V, Fragliasso V, Zanelli M, Vergoni F, Versari A, Rigacci L, Merli F, Ciarrocchi A. A Gene Expression-based Model to Predict Metabolic Response After Two Courses of ABVD in Hodgkin Lymphoma Patients. Clin Cancer Res. 2020 Jan 15;26(2):373-383. doi: 10.1158/1078-0432.CCR-19-2356. Epub 2019 Oct 23.

    PubMed 31645353

  • Rossi D, Spina V, Bruscaggin A, Gaidano G. Liquid biopsy in lymphoma. Haematologica. 2019 Apr;104(4):648-652. doi: 10.3324/haematol.2018.206177. Epub 2019 Mar 7. No abstract available.

    PubMed 30846503

  • Spina V, Bruscaggin A, Cuccaro A, Martini M, Di Trani M, Forestieri G, Manzoni M, Condoluci A, Arribas A, Terzi-Di-Bergamo L, Locatelli SL, Cupelli E, Ceriani L, Moccia AA, Stathis A, Nassi L, Deambrogi C, Diop F, Guidetti F, Cocomazzi A, Annunziata S, Rufini V, Giordano A, Neri A, Boldorini R, Gerber B, Bertoni F, Ghielmini M, Stussi G, Santoro A, Cavalli F, Zucca E, Larocca LM, Gaidano G, Hohaus S, Carlo-Stella C, Rossi D. Circulating tumor DNA reveals genetics, clonal evolution, and residual disease in classical Hodgkin lymphoma. Blood. 2018 May 31;131(22):2413-2425. doi: 10.1182/blood-2017-11-812073. Epub 2018 Feb 15.

    PubMed 29449275

Questions about this trial

What is this clinical trial studying?

An observational study of Classical Hodgkin Lymphoma and Classical Hodgkin Lymphoma Recurrent, run by Azienda USL Reggio Emilia - IRCCS at 12 sites 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 23 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Attilio Gennaro, Clinical Research Coordinator (+39 0522 295175, attilio.gennaro@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic Mutational Profiling of cHL at Progression (time frame: At enrollement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06822855, which also lists 7 linked publications.

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 29 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in