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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448096
Recruitment Status : Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : August 29, 2017
Consortium for Improving Survival of Lymphoma
Information provided by (Responsible Party):
Ho-Young Yhim, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
Large B Cell Diffuse Lymphoma Drug: Rituximab Procedure: Prophylactic intrathecal chemotherapy Phase 2

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 (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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2011
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: primary breast DLBCL
isolated breast involvement with or without nodal disease
Drug: Rituximab
R-CHOP21 consist of rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2, a maximum of 2mg), administered intravenously on day 1 and 100 mg oral prednisone on days 1 through 5.

Procedure: Prophylactic intrathecal chemotherapy
Prophylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: From the date of treatment until the date of disease progression or death from any cause (minimum 2 years) ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: From the date of treatment until the date of death from any cause (minimum 2 years) ]
  2. Number of patients with CNS recurrence [ Time Frame: From the date of treatment until the date of CNS recurrrence (minimum 2 years) ]
  3. Number of patients with adverse events [ Time Frame: From the first date of treatment until 30 days after the last treatment ]
    safety of a combined treatment of R-CHOP21 and prophylactic intrathecal chemotherapy according to the NCI-CTCAE ver.3.0

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448096

Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
Consortium for Improving Survival of Lymphoma
Principal Investigator: Jae-Yong Kwak, MD, PhD Chonbuk National University Hospital

Responsible Party: Ho-Young Yhim, Principal investigator, Chonbuk National University Hospital Identifier: NCT01448096     History of Changes
Other Study ID Numbers: Chonbuk058
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Ho-Young Yhim, Chonbuk National University Hospital:
primary breast diffuse large B cell lymphoma
prophylactic intrathecal chemotherapy
CNS recurrence

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors