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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:


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

  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
  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:

  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

  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