Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

Prospective Data Collection of Elderly Patients (≥ 65 Years) With Diffuse Large B-cell Lymphoma (DLBCL) Receiving at the Time of Diagnosis Multidimensional Geriatric Assessment (VGM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02364050
• Other study ID #: FIL_Elderly Project
• Status: Active, not recruiting
• Start date: September 2013
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).

Description:

Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) to be defined in 3 categories:

• elderly FIT (ADL 6; IADL 8; 0 score= 3-4, < 5 score=2)

• elderly UNIFIT (ADL 5; IADL 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit)

• elderly FRAIL (ADL ≤ 4; IADL ≤ 5; 1 score= 3-4, > 8 score=2; ≥ 80 unfit)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1300
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient with Large B-cell Lymphoma

• Age = 65 years

• informed Consent

Exclusion Criteria:

• Violation of inclusion criteria

• Abscence of data considered essential for the study

• Withdrawal of Consent

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
Italy	AO SS.Antonio e Biagio	Alessandria
Italy	AOU Ospedali Riuniti	Ancona
Italy	CRO-Centro di Riferimento Oncologico	Aviano	Pordenone
Italy	A.O. Universitaria Ospedale Consorziale Policlinico Di Bari	Bari
Italy	IRCC Istituto tumori Ematologia	Bari
Italy	AO Barletta	Barletta
Italy	SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi	Biella
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale Businco	Cagliari
Italy	Ospedale S. Giacomo di Castelfranco Veneto	Castelfranco Veneto	Treviso
Italy	Arnas Garibaldi	Catania
Italy	AO di Cosenza	Cosenza
Italy	AO Santa Croce e Carle	Cuneo
Italy	AOU Careggi	Firenze
Italy	ASL TO-4	Ivrea	Torino
Italy	Polo Pontino	Latina	Roma
Italy	Ematologia Ospedale Vito Fazzi	Lecce
Italy	USL 6 Livorno Centro Aziendale Ematologia	Livorno
Italy	Ospedale di Matera	Matera
Italy	Area Vasta Romagna e IRST	Meldola (FC)
Italy	Ospedali Riuniti Papardo	Messina
Italy	AO Niguarda	Milano
Italy	Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Osp. San Carlo Borromeo Divisione di Oncologia Medica	Milano
Italy	Ospedale S. Raffaele	Milano
Italy	AOU Policlinico di Modena	Modena
Italy	Ospedale San Gerardo	Monza
Italy	AUO Maggiore della Carità	Novara
Italy	AOU Padova	Padova
Italy	Istituto Oncologico Veneto	Padova
Italy	A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo
Italy	A.O. Universitaria Policlinico Giaccone Di Palermo	Palermo
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Fondazione IRCCS Policlinico S.Matteo	Pavia
Italy	AO di Perugia S. Maria della misericordia	Perugia
Italy	Ospedale di Pescara	Pescara
Italy	Ospedale Civile di Piacenza	Piacenza
Italy	Ospedale S. Maria delle Croci	Ravenna
Italy	A.O. Bianchi Melacrino Morelli	Reggio Calabria
Italy	AO Santa Maria Nuova	Reggio Emilia
Italy	Ospedale degli Infermi	Rimini
Italy	CROB	Rionero in Vulture	Potenza
Italy	AOU La Sapienza	Roma
Italy	Azienda OSpedaliera S. Andrea	Roma
Italy	Policlinico Universitario A.Gemelli	Roma
Italy	IRCCS Humanitas	Rozzano	Milano
Italy	AOU Senese	Siena
Italy	AO Santa Maria di Terni	Terni
Italy	AO Città della Salute e della Scienza Ematologia Universitaria	Torino
Italy	AO Città della Salute e della Scienza SC Ematologia	Torino
Italy	Azienda Ospedaliera Caravaggio	Treviglio	Bergamo
Italy	A.O.Cardinale Panico Ematologia e centro trapianti	Tricase	LE
Italy	Ospedale di Circolo	Varese
Italy	Presidio Ospedaliero S. Andrea	Vercelli

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	5 years
Secondary	PFS	Progression free survival	5 years
Secondary	FFS	Failure Free Survival	5 years
Secondary	Response to initial therapy		5 years
Secondary	Early mortality rate		5 years
Secondary	% of patients who performed pre-phase therapy	Come to the prefect Therapy is a steroid-based therapy (administered at dosage of at least 25 mg / day) and / or vincristine, which precedes the beginning of the program of chemoimmunotherapy.	5 years