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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
  • SC Ematologia AO SS. Antonio e Biagio e C. Arrigo

    Alessandria

    Manuela Zanni, MD, manuela.zanni@ospedale.al.it

    Manuela Zanni, MD

    Not yet recruiting
  • Università Politecnica delle Marche - Clinica di Ematologia

    Ancona

    Guido Gini, MD, guido.gini@ospedaliriuniti.marche.it

    Guido Gini, MD

    Recruiting
  • Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

    Avellino

    Giuseppe Rodolfo Nunziata, MD, grnunziata@gmail.com

    Giuseppe Rodolfo Nunziata, MD

    Not yet 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

    Recruiting
  • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

    Barletta

    Giuseppe Tarantini, MD, giuseppetarantini0@gmail.com

    Giuseppe Tarantini, MD

    Not yet recruiting
  • ASST Spedali Civili di Brescia - Ematologia

    Brescia

    Alessandra Tucci, MD, alessandra.tucci@asst-spedalicivili.it

    Alessandra Tucci, MD

    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

    Not yet recruiting
  • Ospedale di Castelfranco Veneto - Ematologia

    Castelfranco Veneto

    Roberto Sartori, MD, roberto.sartori@aulss2.veneto.it

    Roberto Sartori, MD

    Recruiting
  • Azienda Ospedaliera di Cosenza - UOC Ematologia

    Cosenza

    Massimo Gentile, MD, massimogentile@virgilio.it

    Massimo Gentile, MD

    Not yet recruiting
  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence

    Luigi Rigacci, MD, luigi.rigacci@unifi.it

    Luigi Rigacci, MD

    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

    Not yet 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

    Recruiting
  • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia

    Milan

    Andrés Ferreri, MD, andres.ferreri@hsr.it

    Andrés Ferreri, MD

    Not yet 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

    Recruiting
  • AOU di Padova - Ematologia

    Padova

    Livio Trentin, MD, livio.trentin@unipd.it

    Livio Trentin, MD

    Not yet 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

    Recruiting
  • AOU di Parma - UO Ematologia e CTMO

    Parma

    Francesca Re, MD, fre@ao.pr.it

    Francesca Re, MD

    Not yet 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

    Recruiting
  • AO Sant'Andrea - Ematologia

    Roma

    Maria Christina Cox, MD, chrisscox@gmail.com

    Maria Christina Cox, MD

    Not yet recruiting
  • Ospedale S. Camillo - Ematologia

    Roma

    Roberta Battistini, MD, rbattistini@scamilloforlanini.rm.it

    Roberta Battistini, MD

    Recruiting
  • Università Cattolica S. Cuore - Ematologia

    Roma

    Stefan Hohaus, Prof, stefan.hohaus@Unicatt.it

    Stefan Hohaus, MD

    Not yet 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

    Recruiting

Other trials in Italy

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.

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 groups in NCT03552003
Study groupRoleWhat they receive
Newly diagnosed elderly cHL patientsNewly 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted11 Jun 2018
  2. Study start10 Aug 2018
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 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
Prospective
Enrolment
400 participants (estimated)
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

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.

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Clinical Trial NCT03552003 | AzTrials