Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Rituximab

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 0-2.

• 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/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count >= 500/mm^3 and platelet count >= 50,000/mm^3.

• Patients must be age >= 18 years.

• Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.

• Patients must not have an active infection requiring parental antibiotics.

• Patients with known HIV infection are excluded.

• Patients must have a normal left ventricular ejection fraction to be eligible.