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

Not Recruiting

Trial ID: NCT01144754

Purpose

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.

Official Title

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

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)

Eligibility

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.

Intervention(s):

drug: Rituximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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