Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

NCT02555267 | Completed

• 1 other identifier: GERIAD
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma, Large B-cell, Diffuse

Keywords

geriatric assessment; diffuse large B-cell lymphoma; activity of daily living; instrumental activity of daily living; Charlson's comorbidity index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  5 years

• Progression-free survival

  5 years

• Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation

  1 year

Other Outcomes (1)

• Average received relative dose intensity

  6 months

Study Arms (1)

Elderly patients with DLBCL

Elderly patients (age\>=65 years) with DLBCL treated with R-CHOP chemotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• The Catholic University of Korea: collaborator
• Kyungpook National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Korea University Anam Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Kosin University Gospel Hospital: collaborator
• Pusan National University Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Ajou University School of Medicine: collaborator
• Chonnam National University Hospital: collaborator

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ho-Young Yhim, MD, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2020
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

KR (1)