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

Stopped early

Conditions studied: Lymphoma, Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT01144754

Run by

Stanford University

People needed

1

Starts

2009-02-01

Expected to finish

2012-04-01

Last updated by the study team

2016-07-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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