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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Rituximab

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Previously untreated patients with DLBCL of the breast.

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Kristen N. Ganjoo, Stanford University

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 15, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: LYMNHL0071; SU-03042009-1939 (Other Identifier: Stanford University)