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NCT Number: NCT01809600

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

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.

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Key information

Conditions

Burkitt's Lymphoma Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections High-grade B-cell Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • patients with BL or BL-U previously treated with rituximab

Treatment and study plan

No intervention (observational study)

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study 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

Acronym: RBL

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2013
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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