Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)

Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)

This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Large B-cell, Diffuse

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hwasun, Korea, Republic of
    • Chonnam National University Hwasun Hospital
  • Jeonju, Korea, Republic of, 561-712
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly DLBCL patients (≥ 65 years) treated with R-CHOP

Description

Inclusion Criteria:

• Patients with newly diagnosed CD20+ DLBCL
• 65 years old or over
• Scheduled to receive R-CHOP chemotherapy
• Informed consent

Exclusion Criteria:

• Other histology than CD20+ DLBCL
• Primary central nervous system DLBCL
• Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer [papillary or follicular thyroid cancer]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
• Consent withdrawal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elderly DLBCL patients; Elderly DLBCL patients (age>=65 years) treated with R-CHOP chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival	Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Progression-free survival	5 years
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average received ralative dose intensity	The dose intensity of each agent of R-CHOP chemotherapy was calculated by dividing the total received dose of the agent by the number of weeks of treatment. The relative dose intensity of each agents then was calculated by dividing the received dose intensity by the projected dose intensity for the agent. The sum of the relative dose intensities of the individual agents was divided by the number of agents in the R-CHOP to yield the average received relative dose intensity. In this study the average received relative dose intensity is calculated.	6 months

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Collaborators: Pusan National University Hospital; Chonnam National University Hospital; Korea University Anam Hospital; Korea University Guro Hospital; Ajou University School of Medicine; Kyungpook National University Hospital; Yeungnam University Hospital; The Catholic University of Korea; Keimyung University Dongsan Medical Center; Soonchunhyang University Hospital; Chungnam National University Hospital; Kosin University Gospel Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2017
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: diffuse large B-cell lymphoma; activity of daily living; instrumental activity of daily living; Charlson's comorbidity index; geriatric assessments
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: GERIAD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No