Clinical trial NCT02474550: Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma
Official title: Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B Cell Lymphoma
Neutropenia, Febrile
Keywords: diffuse large b cell lymphoma
peg-filgrastim
febrile neutropenia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with DLBCL in Korea

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.

Detailed description: * Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy
* Prphylactic peg-filgrastim on the day after chemotherapy

Eligibility criteria: 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

Primary outcomes:
measure: incidence of febrile neutropenia
timeFrame: within 30 days
Secondary outcomes:
measure: incidence of chemotherapy-related adverse events other than febrile neutropenia
timeFrame: 4 weeks after completion of chemotherapy
measure: Overall survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou Universtiy School of Medicine
state: Kyeonggi
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Yang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung Univerisity Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gill Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk Nationa University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Choong Ang University Hopspital
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Radiological & Medical Science
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Seong Hyun Jeong, M.D
role: PRINCIPAL_INVESTIGATOR
References: