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

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02364050

Enrollment

1300

Registered

2015-02-16

Start date

2013-09-30

Completion date

2020-12-31

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Brief summary

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
OS	5 years	Overall survival

Secondary

Measure	Time frame	Description
PFS	5 years	Progression free survival
FFS	5 years	Failure Free Survival
Response to initial therapy	5 years	—
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.

Countries

Italy

Outcome results