Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

February 2, 2023 updated by: Ho-Young Yhim, Chonbuk National University Hospital

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

This study investigate 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

Study Type

Observational

Enrollment (Actual)

148

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

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

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 (≥ 65 years) with DLBCL 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

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 DLBCL treated with R-CHOP chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 2 years
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
Time Frame: 5 years
5 years
Progression-free survival
Time Frame: 5 years
5 years
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average received relative dose intensity
Time Frame: 6 months
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

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

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
The Catholic University of Korea
Keimyung University Dongsan Medical Center
Soonchunhyang University Hospital
Kosin University Gospel Hospital

Investigators

  • Principal Investigator: Ho-Young Yhim, MD, PhD, Chonbuk National University Hospital

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 (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (ESTIMATE)

September 21, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERIAD

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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