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

High-grade B-cell Lymphoma Clinical Trial

— RBL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809600
• Other study ID #: CISL-1203
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: February 22, 2017
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Burkitt's Lymphoma
• High-grade B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Other:
• No intervention (observational study)

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	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)	one year
Secondary	complete response rate	treatment response will be evaluated according to the Revised criteria for malignant lymphoma (Journal of Clinical Oncology 25:579-586)	1-year
Secondary	overall survival	Overall survival is defined as the time from treatment initiation until death as a result of any cause	1-year
Secondary	Grade 4 hematologic toxicities	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	one year