Diffuse Large B Cell LymphomaNCT02474550
Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma
An observational study of Diffuse Large B Cell Lymphoma and Neutropenia, Febrile, run by Ajou University School of Medicine at 24 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Neutropenia, Febrile
- How many people
- 1,000 participants
- Where
- 24 sitesSouth Korea
- Study dates
- Apr 2015to Dec 2020
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with DLBCL in Korea
Who may be able to join
- 19 or older
- newly diagnosed with DLBCL
- R-CHOP chemotherapy
- offer informed consent
Who cannot join
- other subtype of NHL
- concomitant other cancer
- previous chemotherapy or radiotherapy
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
South Korea24 sites, 24 recruiting
- Recruiting
Soon Chun Yang University Hospital Bucheon
Bucheon-si
- Recruiting
Busan Paik Hospital
Busan
Won Sik Lee
- Recruiting
Chungbuk National University Hospital
Cheongju-si
- Recruiting
Keimyung Univerisity Dongsan Medical Center
Daegu
- Recruiting
Yeungnam University Hospital
Daegu
- Recruiting
Chungnam National University Hospital
Daejeon
- Recruiting
Inje University Ilsan Paik Hospital
Ilsan
- Recruiting
Gachon University Gill Hospital
Incheon
- Recruiting
Chonbuk Nationa University Hospital
Jeonju
- Recruiting
Gyeongsang National University Hospital
Jinju
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Choong Ang University Hopspital
Seoul
- Recruiting
Hallym University Sacred Heart Hospital
Seoul
- Recruiting
Hanyang University Hospital
Seoul
- Recruiting
Hanyang University Medical Center
Seoul
- Recruiting
Inje University Sanggye Paik Hospital
Seoul
- Recruiting
Korea Cancer Center Hospital
Seoul
- Recruiting
Korea Institute of Radiological & Medical Science
Seoul
Hyejin Kang
- Recruiting
Korea University Anam Hospital
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Recruiting
Ajou Universtiy School of Medicine
Suwon, Kyeonggi, 443-721
Geum Sook Jeong, MS, +82-31-219-5990, geumsook@ajou.ac.kr
- Recruiting
Ulsan University Hospital
Ulsan
- Recruiting
Wonju Severance Christian Hospital
Wŏnju
About this study
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.
Read the detailed description
- Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy
- Prphylactic peg-filgrastim on the day after chemotherapy
- Keywords
- diffuse large b cell lymphoma, peg-filgrastim, febrile neutropenia
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
incidence of febrile neutropenia
Measured: within 30 days
Secondary outcomes (2)
incidence of chemotherapy-related adverse events other than febrile neutropenia
Measured: 4 weeks after completion of chemotherapy
Overall survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Hyun Jeong, Ajou University School of Medicine
- Investigators
- Seong Hyun Jeong, M.D, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474550
- Sponsor's protocol ID
- AJIRB-MED-OBS-14-254
- Status last verified
- Jan 2017
- First submitted
- 15 Jun 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02474550
- Acronym / sponsor ID
- AJIRB-MED-OBS-14-254
- Keywords
- diffuse large b cell lymphoma, peg-filgrastim, febrile neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CISL 14-03 | – | –* Patients who were newly diagnosed with Diffuse Large B cell Lymphoma (DLBCL). * Aged 19 or more * Treated with R-CHOP therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with DLBCL in Korea
Key inclusion criteria (4 listed)
- 19 or older
- newly diagnosed with DLBCL
- R-CHOP chemotherapy
- offer informed consent
Key exclusion criteria (3 listed)
- other subtype of NHL
- concomitant other cancer
- previous chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of febrile neutropenia
Time frame: within 30 days
2 secondary outcomes
incidence of chemotherapy-related adverse events other than febrile neutropenia
Time frame: 4 weeks after completion of chemotherapy
Overall survival
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong Hyun Jeong, M.D principal investigator
Ajou University School of Medicine
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma and Neutropenia, Febrile, run by Ajou University School of Medicine at 24 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geum-Sook Jeong (+82-31-219-5989, geumsook@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of febrile neutropenia (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017; AzTrials last refreshed its copy on 27 Oct 2026.