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

Lymphoma, Large B-cell, Diffuse Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211702
• Other study ID #: GERIAD2
• Status: Completed
• Start date: August 25, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2023
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: April 30, 2018
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (13)

Lead Sponsor

Collaborator

Chonbuk National University Hospital

Ajou University School of Medicine, Chonnam National University Hospital, Chungnam National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Kyungpook National University Hospital, Pusan National University Hospital, Soonchunhyang University Hospital, The Catholic University of Korea, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Overall survival		5 years
Secondary	Progression-free survival		5 years
Secondary	Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation		1 year