Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2017

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chonbuk National University Hospital
  • Collaborator
    • The Catholic University of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ho-Young Yhim, Assistant professor – Chonbuk National University Hospital
  • Overall Official(s)
    • Ho-Young Yhim, MD, PhD, Principal Investigator, Chonbuk National University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.