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Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults (RBL)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01809600

First Posted: March 13, 2013

Last Update Posted: February 24, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Junshik Hong, Gachon University Gil Medical Center

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

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: Diffuse Large B-Cell Lymphoma Lymphosarcoma Burkitt Lymphoma B-cell Lymphoma

U.S. FDA Resources

Further study details as provided by Junshik Hong, Gachon University Gil Medical Center:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

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


Enrollment:	43
Study Start Date:	February 2013
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (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 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

Eligibility

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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

Locations


Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760

Sponsors and Collaborators

Gachon University Gil Medical Center

Investigators


Study Director:	Suk Jin Kim, MD, PhD	Samsung Medical Center, Seoul, Korea

More Information


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 Submitted:	March 8, 2013
First Posted:	March 13, 2013
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

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