Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis
- Conditions
- Classical Hodgkin Lymphoma
- Interventions
- Other: Treatment for clinical practise
- Registration Number
- NCT03552003
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Brief 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)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Diagnosis of classical Hodgkin Lymphoma
- Age ≥ 65 year
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Signed informed consent
- Previously untreated patients
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newly diagnosed elderly cHL patients Treatment for clinical practise 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
- Primary Outcome Measures
Name Time Method OS 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
- Secondary Outcome Measures
Name Time Method PFS June 2018-December 2025 (7.5 years) 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.
FFS June 2018-December 2025 (7.5 years) 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.
Response initial therapy June 2018-January 2024 (5.5 years, 6-7 month after the enrolment) Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007
Trial Locations
- Locations (44)
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
🇮🇹Avellino, Italy
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
🇮🇹Aviano, Italy
Azienda Ospedaliera di Cosenza - UOC Ematologia
🇮🇹Cosenza, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
🇮🇹Firenze, Italy
Ospedale Madonna delle Grazie - Ematologia
🇮🇹Matera, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
🇮🇹Milano, Italy
SC Ematologia AO SS. Antonio e Biagio e C. Arrigo
🇮🇹Alessandria, Italy
Università Politecnica delle Marche - Clinica di Ematologia
🇮🇹Ancona, Italy
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
🇮🇹Bari, Italy
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
🇮🇹Barletta, Italy
ASST Spedali Civili di Brescia - Ematologia
🇮🇹Brescia, Italy
Ospedale Businco - Ematologia
🇮🇹Cagliari, Italy
Università Cattolica del Sacro Cuore - Ematologia
🇮🇹Campobasso, Italy
Ospedale di Castelfranco Veneto - Ematologia
🇮🇹Castelfranco Veneto, Italy
UOC Ematologia PO Spaziani
🇮🇹Frosinone, Italy
Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia
🇮🇹Ivrea, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
🇮🇹Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
🇮🇹Milano, Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
🇮🇹Milano, Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia
🇮🇹Milano, Italy
AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
🇮🇹Napoli, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
🇮🇹Novara, Italy
AOU di Padova - Ematologia
🇮🇹Padova, Italy
AOU di Parma - UO Ematologia e CTMO
🇮🇹Parma, Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
🇮🇹Padova, Italy
AOU Policlinico Giaccone - Ematologia
🇮🇹Palermo, Italy
Ospedale S. Maria della Misericordia - Ematologia
🇮🇹Perugia, Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
🇮🇹Pavia, Italy
Ospedale Guglielmo da Saliceto - U.O. Ematologia
🇮🇹Piacenza, Italy
Ospedale delle Croci - Ematologia
🇮🇹Ravenna, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
🇮🇹Reggio Emilia, Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
🇮🇹Rimini, Italy
Istituto Clinico Humanitas - U.O. Ematologia
🇮🇹Rozzano, Italy
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
🇮🇹Sassuolo, Italy
A.O. S. Maria di Terni - S.C. Oncoematologia
🇮🇹Terni, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
🇮🇹Torino, Italy
Ospedale Ca Foncello - S.C di Ematologia
🇮🇹Treviso, Italy
AO Sant'Andrea - Ematologia
🇮🇹Roma, Italy
Ospedale S. Camillo - Ematologia
🇮🇹Roma, Italy
AOU Senese - U.O.C. Ematologia
🇮🇹Siena, Italy
Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio
🇮🇹Sondrio, Italy
A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
🇮🇹Torino, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto
🇮🇹Tricase, Italy
Università Cattolica S. Cuore - Ematologia
🇮🇹Roma, Italy