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

Conditions
Lymphoma, Large B-Cell, Diffuse
Registration Number
NCT02364050
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Brief 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).

Detailed 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 & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
1300
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
OS5 years

Overall survival

Secondary Outcome Measures
NameTimeMethod
Response to initial therapy5 years
PFS5 years

Progression free survival

FFS5 years

Failure Free Survival

Early mortality rate5 years
% of patients who performed pre-phase therapy5 years

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.

Trial Locations

Locations (55)

Azienda Ospedaliera Caravaggio

🇮🇹

Treviglio, Bergamo, Italy

IRCCS Humanitas

🇮🇹

Rozzano, Milano, Italy

CRO-Centro di Riferimento Oncologico

🇮🇹

Aviano, Pordenone, Italy

Ospedale S. Giacomo di Castelfranco Veneto

🇮🇹

Castelfranco Veneto, Treviso, Italy

Ospedale Businco

🇮🇹

Cagliari, Italy

Ospedale San Gerardo

🇮🇹

Monza, Italy

AOU Padova

🇮🇹

Padova, Italy

Fondazione IRCCS Policlinico S.Matteo

🇮🇹

Pavia, Italy

AOU Senese

🇮🇹

Siena, Italy

Ospedale di Circolo

🇮🇹

Varese, Italy

A.O.Cardinale Panico Ematologia e centro trapianti

🇮🇹

Tricase, LE, Italy

CROB

🇮🇹

Rionero in Vulture, Potenza, Italy

Polo Pontino

🇮🇹

Latina, Roma, Italy

ASL TO-4

🇮🇹

Ivrea, Torino, Italy

AOU Careggi

🇮🇹

Firenze, Italy

Ematologia Ospedale Vito Fazzi

🇮🇹

Lecce, Italy

USL 6 Livorno Centro Aziendale Ematologia

🇮🇹

Livorno, Italy

AO Santa Croce e Carle

🇮🇹

Cuneo, Italy

AO SS.Antonio e Biagio

🇮🇹

Alessandria, Italy

AOU Ospedali Riuniti

🇮🇹

Ancona, 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

Area Vasta Romagna e IRST

🇮🇹

Meldola (FC), Italy

Arnas Garibaldi

🇮🇹

Catania, Italy

AO di Cosenza

🇮🇹

Cosenza, Italy

Ospedale di Matera

🇮🇹

Matera, Italy

Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico

🇮🇹

Milano, Italy

Ospedali Riuniti Papardo

🇮🇹

Messina, Italy

Ospedale S. Raffaele

🇮🇹

Milano, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

🇮🇹

Milano, Italy

AO Niguarda

🇮🇹

Milano, Italy

Osp. San Carlo Borromeo Divisione di Oncologia Medica

🇮🇹

Milano, Italy

AOU Policlinico di Modena

🇮🇹

Modena, Italy

AUO Maggiore della Carità

🇮🇹

Novara, Italy

A.O. Ospedali Riuniti Villa Sofia-Cervello

🇮🇹

Palermo, Italy

Azienda Ospedaliero-Universitaria di Parma

🇮🇹

Parma, Italy

A.O. Bianchi Melacrino Morelli

🇮🇹

Reggio Calabria, Italy

Policlinico Universitario A.Gemelli

🇮🇹

Roma, Italy

Istituto Oncologico Veneto

🇮🇹

Padova, Italy

A.O. Universitaria Policlinico Giaccone Di Palermo

🇮🇹

Palermo, Italy

AO Santa Maria Nuova

🇮🇹

Reggio Emilia, Italy

AO Santa Maria di Terni

🇮🇹

Terni, Italy

Presidio Ospedaliero S. Andrea

🇮🇹

Vercelli, Italy

AO di Perugia S. Maria della misericordia

🇮🇹

Perugia, Italy

Ospedale degli Infermi

🇮🇹

Rimini, Italy

AOU La Sapienza

🇮🇹

Roma, Italy

Ospedale di Pescara

🇮🇹

Pescara, Italy

Ospedale Civile di Piacenza

🇮🇹

Piacenza, Italy

Ospedale S. Maria delle Croci

🇮🇹

Ravenna, Italy

Azienda OSpedaliera S. Andrea

🇮🇹

Roma, Italy

AO Città della Salute e della Scienza Ematologia Universitaria

🇮🇹

Torino, Italy

AO Città della Salute e della Scienza SC Ematologia

🇮🇹

Torino, Italy

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