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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2013 by Gachon University Gil Medical Center.
Recruitment status was Recruiting

Sponsor:

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

History of Changes

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: Lymphosarcoma B-cell Lymphoma Burkitt Lymphoma Diffuse Large B-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 (Adult, Senior)
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

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


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 Lymphoma Lymphoma, B-Cell Burkitt Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases	Lymphoma, Non-Hodgkin Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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