Status:
TERMINATED
Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT
Lead Sponsor:
Stanford University
Conditions:
Lymphoma
Non-Hodgkin's Lymphoma
Eligibility:
MALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01144754
Start Date
February 1 2009
End Date
April 1 2012
Last Update
July 1 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305