Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis

Classical Hodgkin Lymphoma Clinical Trial

Official title:

Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552003
• Other study ID #: FIL_ELDHL
• Status: Recruiting
• Start date: August 10, 2018
• Est. completion date: January 2026

Study information

• Verified date: August 2022
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: Vittorio Ruggero Zilioli, MD
• Phone: +39 02 64442668
• Email: vittorioruggero.zilioli[@]ospedaleniguarda.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of classical Hodgkin Lymphoma

2. Age = 65 year

3. Evaluation of Comprehensive Geriatric Assessment at baseline

4. Signed informed consent

5. Previously untreated patients Exclusion Criteria: None

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Other:
• Treatment for clinical practise
Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL

Locations

Country	Name	City	State
Italy	SC Ematologia AO SS. Antonio e Biagio e C. Arrigo	Alessandria
Italy	Università Politecnica delle Marche - Clinica di Ematologia	Ancona
Italy	Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico	Avellino
Italy	Centro Riferimento Oncologico - S.O.C. Oncologia Medica A	Aviano
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	Azienda Ospedaliera di Cosenza - UOC Ematologia	Cosenza
Italy	Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia	Firenze
Italy	UOC Ematologia PO Spaziani	Frosinone
Italy	Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia	Ivrea
Italy	Ospedale Madonna delle Grazie - Ematologia	Matera
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia	Meldola
Italy	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano
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	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova
Italy	AOU Policlinico Giaccone - Ematologia	Palermo
Italy	AOU di Parma - UO Ematologia e CTMO	Parma
Italy	IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia	Pavia
Italy	Ospedale S. Maria della Misericordia - Ematologia	Perugia
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	AO Sant'Andrea - Ematologia	Roma
Italy	Ospedale S. Camillo - Ematologia	Roma
Italy	Università Cattolica S. Cuore - Ematologia	Roma
Italy	Istituto Clinico Humanitas - U.O. Ematologia	Rozzano
Italy	Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico	Sassuolo
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. S. Maria di Terni - S.C. Oncoematologia	Terni
Italy	A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria	Torino
Italy	A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia	Torino
Italy	Ospedale Ca Foncello - S.C di Ematologia	Treviso
Italy	A.O. C. Panico - U.O.C Ematologia e Trapianto	Tricase

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause	June 2018-December 2025 (7.5 years)
Secondary	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.	June 2018-December 2025 (7.5 years)
Secondary	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.	June 2018-December 2025 (7.5 years)
Secondary	Response initial therapy	Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007	June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)