Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT
This study has been terminated.
(Low Accrual)
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01144754
First received: June 14, 2010
Last updated: May 24, 2012
Last verified: May 2012
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Purpose
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 | Intervention |
---|---|
Lymphoma Non-Hodgkin's Lymphoma |
Drug: Rituximab |
Study Type: | Observational |
Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study Population
Previously untreated patients with DLBCL of the breast.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144754
Locations
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: | Kristen N. Ganjoo | Stanford University |
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01144754 History of Changes |
Other Study ID Numbers: | LYMNHL0071, SU-03042009-1939 |
Study First Received: | June 14, 2010 |
Last Updated: | May 24, 2012 |
Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on October 17, 2012