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


N/A
18 Years
N/A
Not Enrolling
Both
Diffuse Large B Cell Lymphoma of the Breast.

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

local and CNS relapse rate

Authority:

Italy: Ethics Committee

Study ID:

IELSG33

NCT ID:

NCT01279772

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Diffuse Large B Cell Lymphoma of the Breast.
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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