PB DLBC
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003935
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 33
(1) Histologically confirmed CD20 positive primary breast DLBCL
(2) No prior chemotherapy, radiotherapy, radical mastectomy with axillary lymph node dissection
(3) 20 = age = 70
(4) Performance status (ECOG) = 2
(5) Cardiac ejection fraction = 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
(6) Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value, Bilirubin < 2 X upper normal value
(7) Adequate renal function: serum creatinine level < 2 mg/dL (177 µmol/L)
(8) Adequate BM functions: hemoglobin = 9 g/dL absolute neutrophil count (ANC) = 1,500/µL and platelet count = 75,000/µL
(9) 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
(10) Life expectancy more than 6 months
(11) Informed consent
(1) other subtype primary breast non-Hodgkin's lymphoma than DLBCL
(2) secondary breast DLBCL
(3) Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
(4) 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.
(5) Pregnant or lactating women, women of childbearing potential not employing adequate contraception
(6) Other serious illness or medical conditions
1) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
2) History of significant neurologic or psychiatric disorders including dementia or seizures
3) Active uncontrolled infection (viral, bacterial or fungal infection)
4) Significant COPD requiring oral steroid treatment or FEV1 < 0.8L on resting pulmonary function test
5) Other serious medical illnesses
6) congenital or acquired bleeding disorders
(7) Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
(8) Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
(9) spine abnormality or disease no to be performed lumbar puncture and intrathecal injection
(10) Patients who donot provide written informed consent form
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method overall survival;cumulative incidence of central nervous system recurrence;safety