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Lymphoma, Large B-Cell, DiffuseNCT02364050

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

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Fondazione Italiana Linfomi - ETS at 55 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
How many people
1,300 participants
Where
55 sitesItaly
Study dates
Sep 2013to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Patient with Large B-cell Lymphoma
  • Age ≥ 65 years
  • informed Consent

Who cannot join

  • Violation of inclusion criteria
  • Abscence of data considered essential for the study
  • Withdrawal of Consent

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

Italy55 sites

  • AO SS.Antonio e Biagio

    Alessandria, 15121

  • AOU Ospedali Riuniti

    Ancona, 60126

  • CRO-Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

    Bari, 70124

  • IRCC Istituto tumori Ematologia

    Bari

  • AO Barletta

    Barletta, 76121

  • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi

    Biella

  • Spedali Civili di Brescia

    Brescia, 25123

  • Ospedale Businco

    Cagliari, 09121

  • Ospedale S. Giacomo di Castelfranco Veneto

    Castelfranco Veneto, Treviso, 31033

  • Arnas Garibaldi

    Catania

  • AO di Cosenza

    Cosenza

  • AO Santa Croce e Carle

    Cuneo, 12100

  • AOU Careggi

    Florence, 50134

  • ASL TO-4

    Ivrea, Torino, 10015

  • Polo Pontino

    Latina, Roma, 04100

  • Ematologia Ospedale Vito Fazzi

    Lecce

  • USL 6 Livorno Centro Aziendale Ematologia

    Livorno, 57124

  • Ospedale di Matera

    Matera, 75100

  • Area Vasta Romagna e IRST

    Meldola (FC)

  • Ospedali Riuniti Papardo

    Messina, 98158

  • Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale S. Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • AO Niguarda

    Milan, 20162

  • Osp. San Carlo Borromeo Divisione di Oncologia Medica

    Milan

  • AOU Policlinico di Modena

    Modena, 41124

  • Ospedale San Gerardo

    Monza

  • AUO Maggiore della Carità

    Novara, 28100

  • Istituto Oncologico Veneto

    Padova, 35128

  • AOU Padova

    Padova

  • A.O. Universitaria Policlinico Giaccone Di Palermo

    Palermo, 90127

  • A.O. Ospedali Riuniti Villa Sofia-Cervello

    Palermo

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • Fondazione IRCCS Policlinico S.Matteo

    Pavia, 27100

  • AO di Perugia S. Maria della misericordia

    Perugia, 06132

  • Ospedale di Pescara

    Pescara, 65124

  • Ospedale Civile di Piacenza

    Piacenza, 29121

  • Ospedale S. Maria delle Croci

    Ravenna

  • A.O. Bianchi Melacrino Morelli

    Reggio Calabria

  • AO Santa Maria Nuova

    Reggio Emilia, 42123

  • Ospedale degli Infermi

    Rimini, 47923

  • CROB

    Rionero in Vulture, Potenza, 85028

  • AOU La Sapienza

    Roma, 00161

  • Policlinico Universitario A.Gemelli

    Roma, 00168

  • Azienda OSpedaliera S. Andrea

    Roma, 00189

  • IRCCS Humanitas

    Rozzano, Milano, 20089

  • AOU Senese

    Siena, 53100

  • AO Santa Maria di Terni

    Terni, 05100

  • AO Città della Salute e della Scienza Ematologia Universitaria

    Torino, 10126

  • AO Città della Salute e della Scienza SC Ematologia

    Torino, 10126

  • Azienda Ospedaliera Caravaggio

    Treviglio, Bergamo, 24127

  • A.O.Cardinale Panico Ematologia e centro trapianti

    Tricase, LE

  • Ospedale di Circolo

    Varese

  • Presidio Ospedaliero S. Andrea

    Vercelli, 13100

Other trials in Italy

About this study

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)

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).

Read the 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)
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02364050
Study groupRoleWhat they receive
Elderly patients with DLBCLElderly patients (Age ≥ 65 years) with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    Overall survival

    Measured: 5 years

Secondary outcomes (5)

  1. PFS

    Progression free survival

    Measured: 5 years

  2. FFS

    Failure Free Survival

    Measured: 5 years

  3. Response to initial therapy

    Measured: 5 years

  4. Early mortality rate

    Measured: 5 years

  5. % 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2017
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364050
Sponsor's protocol ID
FIL_Elderly Project
Status last verified
Feb 2020
First submitted
10 Feb 2015
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Merli F, Luminari S, Tucci A, Arcari A, Rigacci L, Hawkes E, Chiattone CS, Cavallo F, Cabras G, Alvarez I, Fabbri A, Re A, Puccini B, Barraclough A, Delamain MT, Ferrero S, Usai SV, Ferrari A, Cencini E, Pennese E, Zilioli VR, Marino D, Balzarotti M, Cox MC, Zanni M, Di Rocco A, Lleshi A, Botto B, Hohaus S, Merli M, Sartori R, Gini G, Nassi L, Musuraca G, Tani M, Bottelli C, Kovalchuk S, Re F, Flenghi L, Molinari A, Tarantini G, Chimienti E, Marcheselli L, Mammi C, Spina M. Simplified Geriatric Assessment in Older Patients With Diffuse Large B-Cell Lymphoma: The Prospective Elderly Project of the Fondazione Italiana Linfomi. J Clin Oncol. 2021 Apr 10;39(11):1214-1222. doi: 10.1200/JCO.20.02465. Epub 2021 Feb 12.

    PubMed 33577377

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Fondazione Italiana Linfomi - ETS at 55 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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