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

February 5, 2020 updated by: Fondazione Italiana Linfomi ONLUS

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)

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • AO SS.Antonio e Biagio
      • Ancona, Italy, 60126
        • AOU Ospedali Riuniti
      • Bari, Italy, 70124
        • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
      • Bari, Italy
        • IRCC Istituto tumori Ematologia
      • Barletta, Italy, 76121
        • AO Barletta
      • Biella, Italy
        • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
      • Brescia, Italy, 25123
        • Spedali Civili di Brescia
      • Cagliari, Italy, 09121
        • Ospedale Businco
      • Catania, Italy
        • ARNAS Garibaldi
      • Cosenza, Italy
        • AO di Cosenza
      • Cuneo, Italy, 12100
        • AO Santa Croce e Carle
      • Firenze, Italy, 50134
        • AOU Careggi
      • Lecce, Italy
        • Ematologia Ospedale Vito Fazzi
      • Livorno, Italy, 57124
        • USL 6 Livorno Centro Aziendale Ematologia
      • Matera, Italy, 75100
        • Ospedale di Matera
      • Meldola (FC), Italy
        • Area Vasta Romagna e IRST
      • Messina, Italy, 98158
        • Ospedali Riuniti Papardo
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy
        • Osp. San Carlo Borromeo Divisione di Oncologia Medica
      • Milano, Italy, 20132
        • Ospedale S. Raffaele
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico
      • Milano, Italy, 20162
        • AO Niguarda
      • Modena, Italy, 41124
        • AOU Policlinico di Modena
      • Monza, Italy
        • Ospedale San Gerardo
      • Novara, Italy, 28100
        • AUO Maggiore della Carità
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Padova, Italy
        • AOU Padova
      • Palermo, Italy, 90127
        • A.O. Universitaria Policlinico Giaccone Di Palermo
      • Palermo, Italy
        • A.O. Ospedali Riuniti Villa Sofia-Cervello
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico S.Matteo
      • Perugia, Italy, 06132
        • AO di Perugia S. Maria della misericordia
      • Pescara, Italy, 65124
        • Ospedale di Pescara
      • Piacenza, Italy, 29121
        • Ospedale Civile di Piacenza
      • Ravenna, Italy
        • Ospedale S. Maria Delle Croci
      • Reggio Calabria, Italy
        • A.O. Bianchi Melacrino Morelli
      • Reggio Emilia, Italy, 42123
        • AO Santa Maria Nuova
      • Rimini, Italy, 47923
        • Ospedale Degli Infermi
      • Roma, Italy, 00168
        • Policlinico Universitario A.Gemelli
      • Roma, Italy, 00189
        • Azienda OSpedaliera S. Andrea
      • Roma, Italy, 00161
        • AOU La Sapienza
      • Siena, Italy, 53100
        • AOU Senese
      • Terni, Italy, 05100
        • AO Santa Maria di Terni
      • Torino, Italy, 10126
        • AO Città della Salute e della Scienza Ematologia Universitaria
      • Torino, Italy, 10126
        • AO Città della Salute e della Scienza SC Ematologia
      • Varese, Italy
        • Ospedale di Circolo
      • Vercelli, Italy, 13100
        • Presidio Ospedaliero S. Andrea
    • Bergamo
      • Treviglio, Bergamo, Italy, 24127
        • Azienda Ospedaliera Caravaggio
    • LE
      • Tricase, LE, Italy
        • A.O.Cardinale Panico Ematologia e centro trapianti
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IRCCS Humanitas
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • CRO-Centro di Riferimento Oncologico
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85028
        • CROB
    • Roma
      • Latina, Roma, Italy, 04100
        • Polo Pontino
    • Torino
      • Ivrea, Torino, Italy, 10015
        • ASL TO-4
    • Treviso
      • Castelfranco Veneto, Treviso, Italy, 31033
        • Ospedale S. Giacomo di Castelfranco Veneto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elderly patients with DLBCL
Elderly patients (Age ≥ 65 years) with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 5 years
Overall survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 5 years
Progression free survival
5 years
FFS
Time Frame: 5 years
Failure Free Survival
5 years
Response to initial therapy
Time Frame: 5 years
5 years
Early mortality rate
Time Frame: 5 years
5 years
% of patients who performed pre-phase therapy
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Michele Spina, MD, CRO-Centro di Riferimento Oncologico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_Elderly Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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