Skip to main content
Clinical Trials/NCT02364050
NCT02364050
Unknown
Not Applicable

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)

Fondazione Italiana Linfomi - ETS55 sites in 1 country1,300 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphoma, Large B-Cell, Diffuse
Sponsor
Fondazione Italiana Linfomi - ETS
Enrollment
1300
Locations
55
Primary Endpoint
OS
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

OS

Time Frame: 5 years

Overall survival

Secondary Outcomes

  • PFS(5 years)
  • Response to initial therapy(5 years)
  • FFS(5 years)
  • Early mortality rate(5 years)
  • % of patients who performed pre-phase therapy(5 years)

Study Sites (55)

Loading locations...

Similar Trials