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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02474550
Other study ID # AJIRB-MED-OBS-14-254
Secondary ID
Status Recruiting
Phase N/A
First received June 15, 2015
Last updated January 25, 2017
Start date April 2015
Est. completion date December 2020

Study information

Verified date January 2017
Source Ajou University School of Medicine
Contact Geum-Sook Jeong
Phone +82-31-219-5989
Email geumsook@ajou.ac.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

- Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy

- Prphylactic peg-filgrastim on the day after chemotherapy


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Locations

Country Name City State
Korea, Republic of Soon Chun Yang University Hospital Bucheon Bucheon
Korea, Republic of Busan Paik Hospital Busan
Korea, Republic of Chungbuk National University Hospital Cheongju
Korea, Republic of Keimyung Univerisity Dongsan Medical Center Daegu
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan
Korea, Republic of Gachon University Gill Hospital Incheon
Korea, Republic of Chonbuk Nationa University Hospital Jeonju
Korea, Republic of Gyeongsang National University Hospital Jinju
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Choong Ang University Hopspital Seoul
Korea, Republic of Hallym University Sacred Heart Hospital Seoul
Korea, Republic of Hanyang University Hospital Seoul
Korea, Republic of Hanyang University Medical Center Seoul
Korea, Republic of Inje University Sanggye Paik Hospital Seoul
Korea, Republic of Korea Cancer Center Hospital Seoul
Korea, Republic of Korea Institute of Radiological & Medical Science Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Ajou Universtiy School of Medicine Suwon Kyeonggi
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Wonju Severance Christian Hospital Wonju

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of febrile neutropenia within 30 days
Secondary incidence of chemotherapy-related adverse events other than febrile neutropenia 4 weeks after completion of chemotherapy
Secondary Overall survival 2 year
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