Classical Hodgkin LymphomaNCT03552003
Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis
An observational study of Classical Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 44 sites in Italy.
Trial summary
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Treatment for clinical practise
- How many people
- 400 participants
- Where
- 44 sitesItaly
- Study dates
- 10 Aug 2018to Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study.
Who may be able to join
- Diagnosis of classical Hodgkin Lymphoma
- Age ≥ 65 year
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Signed informed consent
- Previously untreated patients
Who cannot join
- None
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Italy44 sites, 44 recruiting
- Not yet recruiting
SC Ematologia AO SS. Antonio e Biagio e C. Arrigo
Alessandria
Manuela Zanni, MD, manuela.zanni@ospedale.al.it
Manuela Zanni, MD
- Recruiting
Università Politecnica delle Marche - Clinica di Ematologia
Ancona
Guido Gini, MD, guido.gini@ospedaliriuniti.marche.it
Guido Gini, MD
- Not yet recruiting
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino
Giuseppe Rodolfo Nunziata, MD, grnunziata@gmail.com
Giuseppe Rodolfo Nunziata, MD
- Recruiting
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano
Michele Spina, MD, mspina@cro.it
Michele Spina, MD
- Recruiting
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
Bari
Giorgina Specchia, Prof, giorgina.specchia@uniba.it
Giorgina Specchia, Prof
- Not yet recruiting
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta
Giuseppe Tarantini, MD, giuseppetarantini0@gmail.com
Giuseppe Tarantini, MD
- Recruiting
ASST Spedali Civili di Brescia - Ematologia
Brescia
Alessandra Tucci, MD, alessandra.tucci@asst-spedalicivili.it
Alessandra Tucci, MD
- Not yet recruiting
Ospedale Businco - Ematologia
Cagliari
Stefania Massidda, MD, smassidda@email.it
Stefania Massidda, MD
- Not yet recruiting
Università Cattolica del Sacro Cuore - Ematologia
Campobasso
Sergio Storti, MD, sergio.storti@unicatt.it
Sergio Storti, MD
- Recruiting
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto
Roberto Sartori, MD, roberto.sartori@aulss2.veneto.it
Roberto Sartori, MD
- Not yet recruiting
Azienda Ospedaliera di Cosenza - UOC Ematologia
Cosenza
Massimo Gentile, MD, massimogentile@virgilio.it
Massimo Gentile, MD
- Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence
Luigi Rigacci, MD, luigi.rigacci@unifi.it
Luigi Rigacci, MD
- Not yet recruiting
UOC Ematologia PO Spaziani
Frosinone
Alessandro Andriani, MD, alessandro.andriani1@tin.it
Alessandro Andriani, MD
- Not yet recruiting
Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia
Ivrea
Roberto Freilone, MD, rfreilone@aslto4.piemonte.it
Roberto Freilone, MD
- Not yet recruiting
Ospedale Madonna delle Grazie - Ematologia
Matera
Alberto Fragasso, MD, alberto.fragasso@libero.it
Alberto Fragasso, MD
- Not yet recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
Meldola
Gerardo Musuraca, MD, g.musuraca@irst.emr.it
Gerardo Musuraca, MD
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it
Vittorio Ruggero Zilioli, MD
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan
Chiara Rusconi, MD, chiara.rusconi@istitutotumori.mi.it
Chiara Rusconi
- Not yet recruiting
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan
Andrés Ferreri, MD, andres.ferreri@hsr.it
Andrés Ferreri, MD
- Recruiting
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia
Milan
Francesca Gaia Rossi, MD, francescagaia.rossi@policlinico.mi.it
Francesca Gaia Rossi, MD
- Recruiting
AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
Naples
Antonello Sica, MD, antonello.sica@fastwebnet.it
Antonello Sica, MD
- Recruiting
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara
Luca Nassi, MD, luca.nassi@med.uniupo.it
Luca Nassi, MD
- Not yet recruiting
AOU di Padova - Ematologia
Padova
Livio Trentin, MD, livio.trentin@unipd.it
Livio Trentin, MD
- Recruiting
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova
Dario Marino, MD, dario.marino@iov.veneto.it
Dario Marino, MD
- Recruiting
AOU Policlinico Giaccone - Ematologia
Palermo
Salvatrice Mancuso, MD, salvatrice.mancuso@unipa.it
Salvatrice Mancuso, MD
- Not yet recruiting
AOU di Parma - UO Ematologia e CTMO
Parma
Francesca Re, MD, fre@ao.pr.it
Francesca Re, MD
- Recruiting
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia
Manuel Gotti, MD, ma.gotti@smatteo.pv.it
Manuel Gotti, MD
- Recruiting
Ospedale S. Maria della Misericordia - Ematologia
Perugia
Leonardo Flenghi, MD, flenghi@yahoo.it
Leonardo Flenghi, MD
- Recruiting
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza
Annalisa Arcari, MD, a.arcari@ausl.pc.it
Annalisa Arcari, MD
- Recruiting
Ospedale delle Croci - Ematologia
Ravenna
Monica Tani, MD, monica.tani@auslromagna.it
Monica Tani, MD
- Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia
Francesco Merli, MD, merli.francesco@ausl.re.it
Francesco Merli, MD
- Recruiting
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini
Anna Lia Molinari, MD, annalia.molinari@auslromagna.it
Anna Lia Molinari, MD
- Not yet recruiting
AO Sant'Andrea - Ematologia
Roma
Maria Christina Cox, MD, chrisscox@gmail.com
Maria Christina Cox, MD
- Recruiting
Ospedale S. Camillo - Ematologia
Roma
Roberta Battistini, MD, rbattistini@scamilloforlanini.rm.it
Roberta Battistini, MD
- Not yet recruiting
Università Cattolica S. Cuore - Ematologia
Roma
Stefan Hohaus, Prof, stefan.hohaus@Unicatt.it
Stefan Hohaus, MD
- Recruiting
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano
Francesca Ricci, MD, francesca.ricci@humanitas.it
Francesca Ricci, MD
- Recruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo
Sara Bigliardi, MD, s.bigliardi@ospedalesassuolo.it
Sara Bigliardi, MD
- Recruiting
AOU Senese - U.O.C. Ematologia
Siena
Alberto Fabbri, MD, fabbri7@unisi.it
Alberto Fabbri, MD
- Recruiting
Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio
Sondrio
Andrea Maria Soccodato, MD, andresocco@alice.it
Andrea Maria Soccodato, MD
- Recruiting
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni
Anna Marina Liberati, Prof, marina.liberati@unipg.it
Anna Marina Liberati, Prof
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
Federica Cavallo, MD, f.cavallo@unito.it
Federica Cavallo, MD
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
Torino
Barbara Botto, MD, bbotto@cittadellasalute.to.it
Barbara Botto, MD
- Recruiting
Ospedale Ca Foncello - S.C di Ematologia
Treviso
Elisabetta Scarpa, MD, elisabetta.scarpa@aulss2.veneto.it
Elisabetta Scarpa, MD
- Recruiting
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase
Vincenzo Pavone, MD, salentoematologia@piafondazionepanico.it
Vincenzo Pavone, MD
About this study
Official title: Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA)
Read the detailed description
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Prospective data collection study of a consecutive series of newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study. Patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Treatment for clinical practise
- Keywords
- Hodgkin, Elderly patients, CGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for clinical practiseOther
Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed elderly cHL patients | Newly diagnosed elderly cHL patients undergoing CGA before any therapy (treatment for clinical practise) with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study Receives: Other: Treatment for clinical practise |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause
Measured: June 2018-December 2025 (7.5 years)
Secondary outcomes (3)
PFS
Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause.
Measured: June 2018-December 2025 (7.5 years)
FFS
Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause.
Measured: June 2018-December 2025 (7.5 years)
Response initial therapy
Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007
Measured: June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start10 Aug 2018
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vittorio Ruggero Zilioli, MD, Principal investigator, SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552003
- Sponsor's protocol ID
- FIL_ELDHL
- Status last verified
- Aug 2022
- First submitted
- 29 May 2018
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis
- ClinicalTrials.gov ID
- NCT03552003
- Acronym / sponsor ID
- FIL_ELDHL
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Hodgkin, Elderly patients, CGA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 11 Jun 2018 (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 aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA)
Detailed description
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Prospective data collection study of a consecutive series of newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study. Patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed elderly cHL patients | – | Other: Treatment for clinical practiseNewly diagnosed elderly cHL patients undergoing CGA before any therapy (treatment for clinical practise) with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study.
Key inclusion criteria (5 listed)
- Diagnosis of classical Hodgkin Lymphoma
- Age ≥ 65 year
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Signed informed consent
- Previously untreated patients
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Treatment for clinical practiseProspective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL | Other | Newly diagnosed elderly cHL patients |
Primary outcome
OS
Time frame: June 2018-December 2025 (7.5 years)
Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause
3 secondary outcomes
PFS
Time frame: June 2018-December 2025 (7.5 years)
FFS
Time frame: June 2018-December 2025 (7.5 years)
Response initial therapy
Time frame: June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
Related trials for Classical Hodgkin Lymphoma
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Active, not recruitingPhase 2
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
Classic Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Active, not recruitingPhase 3
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
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.
Vittorio Ruggero Zilioli, MD principal investigator
SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Classical Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 44 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 5 inclusion and 1 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 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vittorio Ruggero Zilioli, MD (+39 02 64442668, vittorioruggero.zilioli@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: June 2018-December 2025 (7.5 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 26 Aug 2022.