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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.
Information provided by (Responsible Party):
Junshik Hong, Gachon University Gil Medical Center Identifier:
First received: March 8, 2013
Last updated: February 22, 2017
Last verified: February 2017
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:

Further study details as provided by 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

  1. pathologically confirmed BL or BL-U by World Health Organization 2008 criteria
  2. age >20 yrs
  3. received rituximab+chemotherapy as first-line treatment
  4. with measurable or evaluable lesion
  5. with complete set of clinical and laboratory data for the analysis

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

Inclusion Criteria:

  1. 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
  2. age >20 yrs
  3. received rituximab+chemotherapy as first-line treatment
  4. with measurable or evaluable lesion

Exclusion Criteria:

1. patients with BL or BL-U previously treated with rituximab

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Please refer to this study by its identifier: NCT01809600

Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
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 Identifier: NCT01809600     History of Changes
Other Study ID Numbers: CISL-1203
Study First Received: March 8, 2013
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Lymphoma, B-Cell
Burkitt Lymphoma
Neoplasms by Histologic Type
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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 22, 2017