Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

January 25, 2017 updated by: Seong Hyun Jeong, Ajou University School of Medicine
This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL) treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will prospectively collect clinical data and treatment outcome of patients with DLBCL who use prophylactic pegylated-filgrastim.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy
  • Prphylactic peg-filgrastim on the day after chemotherapy

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soon Chun Yang University Hospital Bucheon
      • Busan, Korea, Republic of
        • Recruiting
        • Busan Paik Hospital
        • Contact:
          • Won Sik Lee
      • Cheongju, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung Univerisity Dongsan Medical Center
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
      • Ilsan, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gill Hospital
      • Jeonju, Korea, Republic of
        • Recruiting
        • Chonbuk Nationa University Hospital
      • Jinju, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea Cancer Center Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Choong Ang University Hopspital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea Institute of Radiological & Medical Science
        • Contact:
          • Hyejin Kang
      • Ulsan, Korea, Republic of
        • Recruiting
        • Ulsan University Hospital
      • Wonju, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
    • Kyeonggi
      • Suwon, Kyeonggi, Korea, Republic of, 443-721
        • Recruiting
        • Ajou Universtiy School of Medicine

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with DLBCL in Korea

Description

Inclusion Criteria:

  • 19 or older
  • newly diagnosed with DLBCL
  • R-CHOP chemotherapy
  • offer informed consent

Exclusion Criteria:

  • other subtype of NHL
  • concomitant other cancer
  • previous chemotherapy or radiotherapy

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
CISL 14-03
  • Patients who were newly diagnosed with Diffuse Large B cell Lymphoma (DLBCL).
  • Aged 19 or more
  • Treated with R-CHOP therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of febrile neutropenia
Time Frame: within 30 days
within 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 year
2 year
incidence of chemotherapy-related adverse events other than febrile neutropenia
Time Frame: 4 weeks after completion of chemotherapy
4 weeks after completion of chemotherapy

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Seong Hyun Jeong, M.D, Ajou University School of Medicine

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-OBS-14-254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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