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

Sponsor

Fondazione Italiana Linfomi ONLUS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03552003

Collaborator

(none)

400

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Classical Hodgkin Lymphoma	Other: Treatment for clinical practise

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

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

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

Other: Treatment for clinical practise

Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of classical Hodgkin Lymphoma
Age ≥ 65 year
Evaluation of Comprehensive Geriatric Assessment at baseline
Signed informed consent
Previously untreated patients

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	Country
1	SC Ematologia AO SS. Antonio e Biagio e C. Arrigo	Alessandria	Italy
2	Università Politecnica delle Marche - Clinica di Ematologia	Ancona	Italy
3	Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico	Avellino	Italy
4	Centro Riferimento Oncologico - S.O.C. Oncologia Medica A	Aviano	Italy
5	AOU Policlinico Consorziale - U.O. Ematologia con Trapianto	Bari	Italy
6	Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia	Barletta	Italy
7	ASST Spedali Civili di Brescia - Ematologia	Brescia	Italy
8	Ospedale Businco - Ematologia	Cagliari	Italy
9	Università Cattolica del Sacro Cuore - Ematologia	Campobasso	Italy
10	Ospedale di Castelfranco Veneto - Ematologia	Castelfranco Veneto	Italy
11	Azienda Ospedaliera di Cosenza - UOC Ematologia	Cosenza	Italy
12	Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia	Firenze	Italy
13	UOC Ematologia PO Spaziani	Frosinone	Italy
14	Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia	Ivrea	Italy
15	Ospedale Madonna delle Grazie - Ematologia	Matera	Italy
16	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia	Meldola	Italy
17	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano	Italy
18	Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia	Milano	Italy
19	Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia	Milano	Italy
20	AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia	Napoli	Italy
21	AOU Maggiore della Carità di Novara - SCDU Ematologia	Novara	Italy
22	AOU di Padova - Ematologia	Padova	Italy
23	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova	Italy
24	AOU Policlinico Giaccone - Ematologia	Palermo	Italy
25	AOU di Parma - UO Ematologia e CTMO	Parma	Italy
26	Ospedale S. Maria della Misericordia - Ematologia	Perugia	Italy
27	Ospedale Guglielmo da Saliceto - U.O. Ematologia	Piacenza	Italy
28	Ospedale delle Croci - Ematologia	Ravenna	Italy
29	Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia	Reggio Emilia	Italy
30	Ospedale degli Infermi di Rimini - U.O. di Ematologia	Rimini	Italy
31	AO Sant'Andrea - Ematologia	Roma	Italy
32	Università Cattolica S. Cuore - Ematologia	Roma	Italy
33	Istituto Clinico Humanitas - U.O. Ematologia	Rozzano	Italy
34	Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico	Sassuolo	Italy
35	AOU Senese - U.O.C. Ematologia	Siena	Italy
36	Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio	Sondrio	Italy
37	A.O. S. Maria di Terni - S.C. Oncoematologia	Terni	Italy
38	A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria	Torino	Italy
39	A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia	Torino	Italy
40	A.O. C. Panico - U.O.C Ematologia e Trapianto	Tricase	Italy

Sponsors and Collaborators

Fondazione Italiana Linfomi ONLUS

Investigators

Principal Investigator: Vittorio Ruggero Zilioli, MD, SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Italiana Linfomi ONLUS

ClinicalTrials.gov Identifier:

NCT03552003

Other Study ID Numbers:

FIL_ELDHL

First Posted:

Jun 11, 2018

Last Update Posted:

Jun 14, 2018

Last Verified:

May 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Italiana Linfomi ONLUS

Hodgkin

Elderly patients

CGA

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

No Results Posted as of Jun 14, 2018