Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults (RBL)
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ClinicalTrials.gov Identifier: NCT01809600 |
Recruitment Status
:
Completed
First Posted
: March 13, 2013
Last Update Posted
: February 24, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Burkitt's Lymphoma High-grade B-cell Lymphoma | Other: No intervention (observational study) |
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 Type : | Observational |
Actual Enrollment : | 43 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
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 |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Group/Cohort | Intervention/treatment |
---|---|
Patients with Burkitt's Lymphoma
should be diagnosed pathologically by WHO 2008 criteria
|
Other: No intervention (observational study) |
- 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)
- complete response rate [ Time Frame: 1-year ]treatment response will be evaluated according to the Revised criteria for malignant lymphoma (Journal of Clinical Oncology 25:579-586)
- overall survival [ Time Frame: 1-year ]Overall survival is defined as the time from treatment initiation until death as a result of any cause
- Grade 4 hematologic toxicities [ Time Frame: one year ]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

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
1. patients with BL or BL-U previously treated with rituximab

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809600
Korea, Republic of | |
Gachon University Gil Medical Center | |
Incheon, Korea, Republic of, 405-760 |
Study Director: | Suk Jin Kim, MD, PhD | Samsung Medical Center, Seoul, Korea |
Responsible Party: | Junshik Hong, Assistant Professor, Department of Internal Medicine, Gachon University Gil Medical Center |
ClinicalTrials.gov Identifier: | NCT01809600 History of Changes |
Other Study ID Numbers: |
CISL-1203 |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, B-Cell Burkitt Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |