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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02364050
Other study ID # FIL_Elderly Project
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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