Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults (RBL)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2013 by Gachon University Gil Medical Center
Sponsor:
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Junshik Hong, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01809600
First received: March 8, 2013
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burkitt's Lymphoma High-grade B-cell Lymphoma |
Other: No intervention (observational study) |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Genetic and Rare Diseases Information Center resources:
B-cell Lymphomas
Burkitt Lymphoma
Lymphosarcoma
Small Non-cleaved Cell Lymphoma
U.S. FDA Resources
Further study details as provided by Gachon University Gil Medical Center:
Primary Outcome Measures:
- Event-free survival [ Time Frame: one year ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- complete response rate [ Time Frame: 1-year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 55 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with Burkitt's Lymphoma
should be diagnosed pathologically by WHO 2008 criteria
|
Other: No intervention (observational study) |
Detailed Description:
Inclusion criteria
- pathologically confirmed BL or BL-U by WHO 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
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients who were treated with Burkitt's or Burkitt-like high-grade B-cell lymphoma in Republic of Korea
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809600
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809600
Contacts
| Contact: Junshik Hong, MD | +82-10-3395-8656 | alertjun@hanmail.net |
Locations
| Korea, Republic of | |
| Gachon University Gil Medical Center | Recruiting |
| Incheon, Korea, Republic of, 405-760 | |
| Contact: Junshik Hong, MD alertjun@hanmail.net | |
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
| Study Director: | Suk Jin Kim, MD, PhD | Samsung Medical Center, Seoul, Korea |
More Information
No publications provided
| 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 |
| Study First Received: | March 8, 2013 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Epstein-Barr Virus Infections Burkitt Lymphoma Lymphoma Lymphoma, B-Cell DNA Virus Infections Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders |
Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Experimental Tumor Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015