Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University


  • Drug: Rituximab




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

   - Patients must not have historical or radiographic evidence of CNS metastasis including
   previously treated, resected or asymptomatic brain lesions or leptomeningeal

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305