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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211702
Recruitment Status : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
The Catholic University of Korea
Kyungpook National University Hospital
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Korea University Guro Hospital
Kosin University Gospel Hospital
Pusan National University Hospital
Soonchunhyang University Hospital
Ajou University School of Medicine
Chonnam National University Hospital
Chungnam National University Hospital
Yeungnam University Hospital
Information provided by (Responsible Party):
Ho-Young Yhim, Chonbuk National University Hospital

Brief 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.

Condition or disease
Lymphoma, Large B-cell, Diffuse

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : August 25, 2017
Actual Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. Progression-free survival [ Time Frame: 5 years ]
  3. Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Average received ralative 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Elderly DLBCL patients (≥ 65 years) treated with R-CHOP
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211702


Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
The Catholic University of Korea
Kyungpook National University Hospital
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Korea University Guro Hospital
Kosin University Gospel Hospital
Pusan National University Hospital
Soonchunhyang University Hospital
Ajou University School of Medicine
Chonnam National University Hospital
Chungnam National University Hospital
Yeungnam University Hospital
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Responsible Party: Ho-Young Yhim, Assistant professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03211702    
Other Study ID Numbers: GERIAD2
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ho-Young Yhim, Chonbuk National University Hospital:
geriatric assessments
diffuse large B-cell lymphoma
activity of daily living
instrumental activity of daily living
Charlson's comorbidity index
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin