Burkitt's LymphomaRBLNCT01809600
Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults
An observational study of Burkitt's Lymphoma and High-grade B-cell Lymphoma, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
This retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Burkitt's Lymphoma, High-grade B-cell Lymphoma
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were treated with Burkitt's or Burkitt-like high-grade B-cell lymphoma in Republic of Korea
Who may be able to join
- pathologically confirmed Burkitt's lymphoma (BL) or High grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL (BL-U) by WHO 2008 criteria
- age >20 yrs
- received rituximab+chemotherapy as first-line treatment
- with measurable or evaluable lesion
Who cannot join
- 1. patients with BL or BL-U previously treated with rituximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rituximab-Containing Immunochemotherapy for Burkitt's Lymphoma (BL) and High-Grade B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and BL
This retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL.
Read the detailed description
Inclusion criteria
- pathologically confirmed BL or BL-U by World Health Organization 2008 criteria
- age >20 yrs
- received rituximab+chemotherapy as first-line treatment
- with measurable or evaluable lesion
- with complete set of clinical and laboratory data for the analysis
- Conditions
- Burkitt's Lymphoma, High-grade B-cell Lymphoma
- Being tested
- No intervention (observational study)
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with Burkitt's Lymphoma | should be diagnosed pathologically by WHO 2008 criteria Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Event-free survival is measured from the time from treatment initiation to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death)
Measured: one year
Secondary outcomes (3)
complete response rate
treatment response will be evaluated according to the Revised criteria for malignant lymphoma (Journal of Clinical Oncology 25:579-586)
Measured: 1-year
overall survival
Overall survival is defined as the time from treatment initiation until death as a result of any cause
Measured: 1-year
Grade 4 hematologic toxicities
toxicities will be graded according to Common Toxicity Criteria for Adverse Events (CTCAE) V.4.0. Hematologic toxicities planned to evaluated were; anemia (by hemoglobin), absolute neutrophil count, and platelet count
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burkitt's 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junshik Hong, Gachon University Gil Medical Center
- Investigators
- Suk Jin Kim, MD, PhD, Study director, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809600
- Sponsor's protocol ID
- CISL-1203
- Acronym
- RBL
- Status last verified
- Feb 2017
- First submitted
- 8 Mar 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab-Containing Immunochemotherapy for Burkitt's Lymphoma (BL) and High-Grade B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and BL
- ClinicalTrials.gov ID
- NCT01809600
- Acronym / sponsor ID
- RBL / CISL-1203
- Conditions
- Burkitt's Lymphoma, High-grade B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Mar 2013 (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 retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL.
Detailed description
Inclusion criteria
- pathologically confirmed BL or BL-U by World Health Organization 2008 criteria
- age >20 yrs
- received rituximab+chemotherapy as first-line treatment
- with measurable or evaluable lesion
- with complete set of clinical and laboratory data for the analysis
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Burkitt's Lymphoma | – | Other: No intervention (observational study)should be diagnosed pathologically by WHO 2008 criteria |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were treated with Burkitt's or Burkitt-like high-grade B-cell lymphoma in Republic of Korea
Key inclusion criteria (4 listed)
- pathologically confirmed Burkitt's lymphoma (BL) or High grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL (BL-U) by WHO 2008 criteria
- age >20 yrs
- received rituximab+chemotherapy as first-line treatment
- with measurable or evaluable lesion
Key exclusion criteria (1 listed)
- 1. patients with BL or BL-U previously treated with rituximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study) | Other | Patients with Burkitt's Lymphoma |
Primary outcome
Event-free survival
Time frame: one year
Event-free survival is measured from the time from treatment initiation to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death)
3 secondary outcomes
complete response rate
Time frame: 1-year
overall survival
Time frame: 1-year
Grade 4 hematologic toxicities
Time frame: one 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 24 Feb 2017.
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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.
Suk Jin Kim, MD, PhD study director
Samsung Medical Center, Seoul, Korea
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 Burkitt's Lymphoma and High-grade B-cell Lymphoma, run by Gachon University Gil Medical Center 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 4 inclusion and 1 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 24 Feb 2017. 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?
Event-free survival (time frame: one year). 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 24 Feb 2017.