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

Completed

• Conditions: Burkitt's Lymphoma; High-grade B-cell Lymphoma
• Interventions: Other: No intervention (observational study)

• Registration Number: NCT01809600
• Lead Sponsor: Gachon University Gil Medical Center

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Burkitt's Lymphoma	No intervention (observational study)	should be diagnosed pathologically by WHO 2008 criteria

Primary Outcome Measures

Name	Time	Method
Event-free survival	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

Name	Time	Method
complete response rate	1-year	treatment response will be evaluated according to the Revised criteria for malignant lymphoma (Journal of Clinical Oncology 25:579-586)
overall survival	1-year	Overall survival is defined as the time from treatment initiation until death as a result of any cause
Grade 4 hematologic toxicities	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

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of