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

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ClinicalTrials.gov Identifier: NCT01809600
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Junshik Hong, Gachon University Gil Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Burkitt's Lymphoma High-grade B-cell Lymphoma 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

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 43 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients with Burkitt's Lymphoma
should be diagnosed pathologically by WHO 2008 criteria
 Other: No intervention (observational study)


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. overall survival [ Time Frame: 1-year ]
    Overall survival is defined as the time from treatment initiation until death as a result of any cause

  3. 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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: March 13, 2013    Key Record Dates
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