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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144754
Recruitment Status : Terminated (Low Accrual)
First Posted : June 16, 2010
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
Stanford University

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 months. Patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.

Condition or disease Intervention/treatment
Lymphoma Non-Hodgkin's Lymphoma Drug: Rituximab

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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 RCHOP With or Without Radiotherapy
Study Start Date : February 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Intervention Details:
  • Drug: Rituximab
    Calculated per patient
    Other Names:
    • Rituxan
    • MabThera

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously untreated patients with 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144754

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Kristen N. Ganjoo Stanford University
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Responsible Party: Stanford University Identifier: NCT01144754    
Other Study ID Numbers: LYMNHL0071
SU-03042009-1939 ( Other Identifier: Stanford University )
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents