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This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas (IELSG33)

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ClinicalTrials.gov Identifier: NCT01279772
Recruitment Status : Terminated (due to slow accrual (only 1 patient entered))
First Posted : January 19, 2011
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
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.

Condition or disease
Diffuse Large B-Cell Lymphoma of the Breast

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
Study Start Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. local and CNS relapse rate [ Time Frame: 12-month ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 12-month ]
  2. overall survival [ Time Frame: 5-year ]
  3. overall, complete and partial response rates following RCHOP [ Time Frame: at the end of chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously untreated patients with localized DLBCL of the breast.

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

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT01279772     History of Changes
Other Study ID Numbers: IELSG33
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: July 2012

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin