This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas

Terminated

• Conditions: Diffuse Large B-Cell Lymphoma of the Breast

• Registration Number: NCT01279772
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Brief Summary

In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Study Start: 2011-10
• Status Verified: 2012-07
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 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/mm3 and platelet count > 50,000/mm3.

• Patients must be age > 18 years.

• Patients must have a normal left ventricular ejection fraction to be eligible.

Exclusion Criteria

• historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
• pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
• active infection requiring parental antibiotics.
• known HIV infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local and CNS relapse rate	12-month

Secondary Outcome Measures

Name	Time	Method
progression free survival	12-month
overall survival	5-year
overall, complete and partial response rates following RCHOP	at the end of chemotherapy