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)

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-16
• Primary Completion: 2017-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06
• Study Completion: 2020-12

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

Name	Time	Method
OS	5 years	Overall survival

Secondary Outcome Measures

Name	Time	Method
PFS	5 years	Progression free survival
Early mortality rate	5 years
% of patients who performed pre-phase therapy	5 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.
Response to initial therapy	5 years
FFS	5 years	Failure Free Survival

Trial Locations

Locations (55)

Azienda Ospedaliera Caravaggio; 🇮🇹 Treviglio, Bergamo, Italy

A.O.Cardinale Panico Ematologia e centro trapianti; 🇮🇹 Tricase, LE, Italy

IRCCS Humanitas; 🇮🇹 Rozzano, Milano, Italy

CRO-Centro di Riferimento Oncologico; 🇮🇹 Aviano, Pordenone, Italy

CROB; 🇮🇹 Rionero in Vulture, Potenza, Italy

Polo Pontino; 🇮🇹 Latina, Roma, Italy

ASL TO-4; 🇮🇹 Ivrea, Torino, Italy

Ospedale S. Giacomo di Castelfranco Veneto; 🇮🇹 Castelfranco Veneto, Treviso, Italy

AO SS.Antonio e Biagio; 🇮🇹 Alessandria, Italy

AOU Ospedali Riuniti; 🇮🇹 Ancona, Italy

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