NCT02474550

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

3.7 years

First QC Date

June 15, 2015

Last Update Submit

January 25, 2017

Conditions

Diffuse Large B Cell LymphomaNeutropenia, Febrile

Keywords

diffuse large b cell lymphomapeg-filgrastimfebrile neutropenia

Outcome Measures

Primary Outcomes (1)

  • incidence of febrile neutropenia

    within 30 days

Secondary Outcomes (2)

  • incidence of chemotherapy-related adverse events other than febrile neutropenia

    4 weeks after completion of chemotherapy

  • Overall survival

    2 year

Study Arms (1)

CISL 14-03

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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with DLBCL in Korea

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Ajou Universtiy School of Medicine

Suwon, Kyeonggi, 443-721, South Korea

RECRUITING

Soon Chun Yang University Hospital Bucheon

Bucheon-si, South Korea

RECRUITING

Busan Paik Hospital

Busan, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, South Korea

RECRUITING

Keimyung Univerisity Dongsan Medical Center

Daegu, South Korea

RECRUITING

Yeungnam University Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, South Korea

RECRUITING

Gachon University Gill Hospital

Incheon, South Korea

RECRUITING

Chonbuk Nationa University Hospital

Jeonju, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Choong Ang University Hopspital

Seoul, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Hanyang University Hospital

Seoul, South Korea

RECRUITING

Hanyang University Medical Center

Seoul, South Korea

RECRUITING

Inje University Sanggye Paik Hospital

Seoul, South Korea

RECRUITING

Korea Cancer Center Hospital

Seoul, South Korea

RECRUITING

Korea Institute of Radiological & Medical Science

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseFebrile Neutropenia

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte Disorders

Study Officials

  • Seong Hyun Jeong, M.D

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geum-Sook Jeong

CONTACT

+82-31-219-5989geumsook@ajou.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 17, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(24)