Status:
COMPLETED
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
Lead Sponsor:
Chonbuk National University Hospital
Collaborating Sponsors:
Consortium for Improving Survival of Lymphoma
Conditions:
Large B Cell Diffuse Lymphoma
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to clarify the impact of rituximab on clinical outcomes in patients with primary breast diffuse large B-cell lymphoma and also to investigate the role of prophylactic intr...
Detailed Description
Primary breast diffuse large B-cell lymphoma (DLBCL) is a rare presentation of non-Hodgkin's lymphoma. A significant risk of contralateral breast involvement and a tendency for central nervous system ...
Eligibility Criteria
Inclusion
- Histologically confirmed CD20 positive primary breast DLBCL
- age ≤ 70
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (ECOG) ≤ 2
- Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
- Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
- Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value, Bilirubin \< 2 X upper normal value
- Adequate BM functions: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
- A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause
- Life expectancy more than 6 months
- Informed consent
Exclusion
- other subtype primary breast non-Hodgkin's lymphoma than DLBCL
- secondary breast DLBCL
- Patients with a known history of HIV seropositivity or HCV (+). Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01448096
Start Date
August 1 2011
End Date
July 10 2019
Last Update
August 7 2019
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea, 561-712