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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01144754
• Other study ID #: LYMNHL0071
• Secondary ID: SU-03042009-1939
• Status: Terminated
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 29, 2016
• Start date: February 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Rituximab
Calculated per patient

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States,