Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma

• Status: Completed
• Trial end date: 2019-07-10
• Target enrollment: 0
• Participant gender: Female

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 intrathecal chemotherapy using methotrexate for reducing central nervous system (CNS) recurrence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonbuk National University Hospital
• Collaborators: Consortium for Improving Survival of Lymphoma; Consortium for Improving Survival on Lymphoma
• Treatments: Cyclophosphamide; Methotrexate; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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