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

NCT01144754 | Terminated DMC

• 2 other identifiers: LYMNHL0071SU-03042009-1939
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma; Non-Hodgkin's Lymphoma

Interventions

Rituximab DRUG

Calculated per patient

Also known as: Rituxan, MabThera

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously untreated patients with DLBCL of the breast.

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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kristen N. Ganjoo

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: February 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (1)