A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP With or Without Radiotherapy

Stanford University1 site in 1 country1 target enrollmentFebruary 2009

ConditionsLymphoma Non-Hodgkin's Lymphoma

DrugsRituximab

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lymphoma
Sponsor: Stanford University
Enrollment: 1
Locations: 1
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center observational study to assess addition of Rituximab in the treatment of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an enrollment period of 60 months. Patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

April 2012

Last Updated

9 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously untreated patients with DLBCL of the breast.
•Patients must have CD20 positive tumors.
•Stage IE or IIE.
•Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
•Patients must not have historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
•Patients must have an ECOG performance status 0-
•Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration):
•Creatinine Clearance \>= 50 ml/min
•Total bilirubin \<= 2.0 mg/dl and AST \<= 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be \<= 3 x \*ULN, and AST \<= 5 x ULN.
•Absolute neutrophil count \>= 1500/mm3 and platelet count \>= 100,000/mm