Lymphoma, Large B-Cell, DiffuseNCT01266668
The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)
An observational study of Lymphoma, Large B-Cell, Diffuse, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Jun 2011
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary breast DLBCL group was identified from the nation-wide surveys in the university hospital, general hospital, and cancer institute of Korea. And, the nodal DLBCL group, as a matching control group, was selected from the data registry of Korean Society of Hematology Lymphoma Working Party.
Who may be able to join
- Stage I or II of primary breast DLBCL treated with R-CHOP
- Stage I or II of nodal DLBCL treated with R-CHOP
- Definition of primary breast DLBCL - Isolated breast involvement with or without nodal disease, which include distant nodal disease as well as regional nodal disease
- Definition of nodal DLBCL
- The disease was only limited to the lymph nodes or lymphoid organs
Who cannot join
- Primary breast DLBCL or nodal DLBCL treated without rituximab
- Secondary breast DLBCL
- Recurrent DLBCL
- Stage III or IV of nodal DLBCL with extranodal involvement as a dissemination process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Matched Pair Analysis Comparing the Outcomes of Primary Breast and Nodal Diffuse Large B Cell Lymphoma in Patients Treated With R-CHOP; Consortium for Improving Survival of Lymphoma (CISL) Study
The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen.
Read the detailed description
Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma. Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying this, a large randomized trial comparing survival in patients with primary breast DLBCL is required. However, the rarity of primary breast DLBCL makes large trial virtually difficult in single center or study group. Additionally, retrospective studies for evaluating the role of rituximab in primary breast DLBCL had bias according to the difference of treatment period between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival and patterns of progression in patients with primary breast DLBCL, the investigators performed this matched pair analysis following strict matching criteria in patients with primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma Working Party, treated with R-CHOP regimen.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Diffuse large B cell lymphoma, Breast, Rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
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 |
|---|---|---|
| Primary breast DLBCL | Primary breast DLBCL was defined as that involving single extranodal organ (i.e. breast) regardless of the status of nodal disease. | |
| Nodal DLBCL | The disease was only limited to the lymph nodes or lymphoid organs without extranodal organ involvements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 year
Secondary outcomes (1)
Progression-free survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Young Yhim, Chonbuk National University Hospital
- Investigators
- Jae-Yong Kwak, MD.,PhD., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266668
- Sponsor's protocol ID
- Chonbuk 011
- Status last verified
- Nov 2011
- First submitted
- 21 Dec 2010
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yhim HY, Kim JS, Kang HJ, Kim SJ, Kim WS, Choi CW, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Huh J, Lee DH, Suh C, Kwak JY. Matched-pair analysis comparing the outcomes of primary breast and nodal diffuse large B-cell lymphoma in patients treated with rituximab plus chemotherapy. Int J Cancer. 2012 Jul 1;131(1):235-43. doi: 10.1002/ijc.26352. Epub 2011 Aug 30.
PubMed 21823120
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matched Pair Analysis Comparing the Outcomes of Primary Breast and Nodal Diffuse Large B Cell Lymphoma in Patients Treated With R-CHOP; Consortium for Improving Survival of Lymphoma (CISL) Study
- ClinicalTrials.gov ID
- NCT01266668
- Acronym / sponsor ID
- Chonbuk 011
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Diffuse large B cell lymphoma, Breast, Rituximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Dec 2010 (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.
The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen.
Detailed description
Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma. Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying this, a large randomized trial comparing survival in patients with primary breast DLBCL is required. However, the rarity of primary breast DLBCL makes large trial virtually difficult in single center or study group. Additionally, retrospective studies for evaluating the role of rituximab in primary breast DLBCL had bias according to the difference of treatment period between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival and patterns of progression in patients with primary breast DLBCL, the investigators performed this matched pair analysis following strict matching criteria in patients with primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma Working Party, treated with R-CHOP regimen.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary breast DLBCL | – | –Primary breast DLBCL was defined as that involving single extranodal organ (i.e. breast) regardless of the status of nodal disease. |
| Nodal DLBCL | – | –The disease was only limited to the lymph nodes or lymphoid organs without extranodal organ involvements. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary breast DLBCL group was identified from the nation-wide surveys in the university hospital, general hospital, and cancer institute of Korea. And, the nodal DLBCL group, as a matching control group, was selected from the data registry of Korean Society of Hematology Lymphoma Working Party.
Key inclusion criteria (5 listed)
- Stage I or II of primary breast DLBCL treated with R-CHOP
- Stage I or II of nodal DLBCL treated with R-CHOP
- Definition of primary breast DLBCL - Isolated breast involvement with or without nodal disease, which include distant nodal disease as well as regional nodal disease
- Definition of nodal DLBCL
- The disease was only limited to the lymph nodes or lymphoid organs
Key exclusion criteria (4 listed)
- Primary breast DLBCL or nodal DLBCL treated without rituximab
- Secondary breast DLBCL
- Recurrent DLBCL
- Stage III or IV of nodal DLBCL with extranodal involvement as a dissemination process
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
Overall Survival
Time frame: 3 year
1 secondary outcome
Progression-free survival
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
- Derived from this study: PubMed 21823120Yhim HY, Kim JS, Kang HJ, Kim SJ, Kim WS, Choi CW, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Huh J, Lee DH, Suh C, Kwak JY. Matched-pair analysis comparing the outcomes of primary breast and nodal diffuse large B-cell lymphoma in patients treated with rituximab plus chemotherapy. Int J Cancer. 2012 Jul 1;131(1):235-43. doi: 10.1002/ijc.26352. Epub 2011 Aug 30.
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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.
Jae-Yong Kwak, MD.,PhD. principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Large B-Cell, Diffuse, run by Chonbuk National University Hospital at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266668, which also lists 1 linked publication.
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 29 Nov 2011.