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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Gachon University Gil Medical Center
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
  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 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

  1. pathologically confirmed BL or BL-U by WHO 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

Ages Eligible for Study:   20 Years and older
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:

  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
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

No publications provided

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, B-Cell
Burkitt Lymphoma
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms, Experimental

ClinicalTrials.gov processed this record on September 30, 2014