Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Large B Cell Diffuse Lymphoma |
Drug: Rituximab Procedure: Prophylactic intrathecal chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- progression-free survival [ Time Frame: From the date of treatment until the date of disease progression or death from any cause (minimum 2 years) ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: From the date of treatment until the date of death from any cause (minimum 2 years) ] [ Designated as safety issue: No ]
- Number of patients with CNS recurrence [ Time Frame: From the date of treatment until the date of CNS recurrrence (minimum 2 years) ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: From the first date of treatment until 30 days after the last treatment ] [ Designated as safety issue: Yes ]safety of a combined treatment of R-CHOP21 and prophylactic intrathecal chemotherapy according to the NCI-CTCAE ver.3.0
| Estimated Enrollment: | 33 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
-
Drug: Rituximab
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 (CNS) progression have been identified in previous studies. Optimal treatment strategies for primary breast DLBCL have remained undefined, although the combination of anthracycline-based chemotherapy and radiotherapy may be considered to be the best treatment option in these studies. However, despite the administration of aggressive treatment, prognosis is still poor, even in localized disease, with 5-year progression-free survival rates of approximately 50% to 65% in most series. Therefore, other therapeutic options must be explored.
During the last decade, several studies have shown that rituximab plus CHOP or CHOP-like chemotherapy significantly improves clinical outcomes of patients with DLBCL. However, the relevance of rituximab in the management of this rare extranodal lymphoma has never been studied. Moreover, several studies have also suggested the possibility that prophylactic intrathecal chemotherapy might be effective in reducing CNS recurrence.
Thus, this trial is designed to prospectively evaluate the treatment strategy, which addressed the safety and efficacy of a combined therapy that included R-CHOP21 and prophylactic intrathecal chemotherapy using methotrexate.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Ho-Young Yhim, MD | 82-63-250-2523 | yhimhy@jbnu.ac.kr |
| Korea, Republic of | |
| Chonbuk National University Hospital | Recruiting |
| Jeonju, Korea, Republic of, 561-712 | |
| Contact: Ho-Young Yhim, MD 82-63-250-2523 yhimhy@jbnu.ac.kr | |
| Principal Investigator: Jae-Yong Kwak, MD, PhD | |
| Principal Investigator: | Jae-Yong Kwak, MD, PhD | Chonbuk National University Hospital |
More Information
No publications provided
| Responsible Party: | Ho-Young Yhim, Principal investigator, Chonbuk National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01448096 History of Changes |
| Other Study ID Numbers: | Chonbuk058 |
| Study First Received: | October 5, 2011 |
| Last Updated: | October 6, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chonbuk National University Hospital:
|
primary breast diffuse large B cell lymphoma rituximab prophylactic intrathecal chemotherapy CNS recurrence Primary breast diffuse large B cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Methotrexate Rituximab Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013