Clinical trial · Interventional
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
Multi-center Phase II Study of the Combination of R-CHOP (RItuximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) and Prophylactic Intrathecal Chemotherapy With Methotrexate in Patients With CD20+ Primary Breast Diffuse Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large B Cell Diffuse Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic intrathecal chemotherapy | Procedure | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- primary breast DLBCL
- description
- isolated breast involvement with or without nodal disease
- interventionNames
- Drug: Rituximab
- Procedure: Prophylactic intrathecal chemotherapy
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- From the date of treatment until the date of disease progression or death from any cause (minimum 2 years)
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- From the date of treatment until the date of death from any cause (minimum 2 years)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDYhim HY, Kim JS, Kang HJ, Kim SJ, Kim WS, Choi CW, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Huh J, Lee DH, Suh C, Kwak JY. Matched-pair analysis comparing the outcomes of primary breast and nodal diffuse large B-cell lymphoma in patients treated with rituximab plus chemotherapy. Int J Cancer. 2012 Jul 1;131(1):235-43. doi: 10.1002/ijc.26352. Epub 2011 Aug 30. PMID 21823120
- BACKGROUNDYhim HY, Kang HJ, Choi YH, Kim SJ, Kim WS, Chae YS, Kim JS, Choi CW, Oh SY, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Lee JJ, Sung HJ, Kim HJ, Lee DH, Suh C, Kwak JY. Clinical outcomes and prognostic factors in patients with breast diffuse large B cell lymphoma; Consortium for Improving Survival of Lymphoma (CISL) study. BMC Cancer. 2010 Jun 22;10:321. doi: 10.1186/1471-2407-10-321. PMID 20569446