Back to resultsStudy in Patients With Primary Breast Diffuse Large B-cell Lymphoma
Primary Purpose
Large B Cell Diffuse Lymphoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab
Prophylactic intrathecal chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Large B Cell Diffuse Lymphoma focused on measuring primary breast diffuse large B cell lymphoma, rituximab, prophylactic intrathecal chemotherapy, CNS recurrence
Eligibility 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
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
primary breast DLBCL
Arm Description
isolated breast involvement with or without nodal disease
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
overall survival
Number of patients with CNS recurrence
Number of patients with adverse events
safety of a combined treatment of R-CHOP21 and prophylactic intrathecal chemotherapy according to the NCI-CTCAE ver.3.0
Full Information
NCT ID
NCT01448096
First Posted
October 5, 2011
Last Updated
August 5, 2019
Sponsor
Chonbuk National University Hospital
Collaborators
Consortium for Improving Survival of Lymphoma
1. Study Identification
Unique Protocol Identification Number
NCT01448096
Brief Title
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
Collaborators
Consortium for Improving Survival of Lymphoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large B Cell Diffuse Lymphoma
Keywords
primary breast diffuse large B cell lymphoma, rituximab, prophylactic intrathecal chemotherapy, CNS recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
primary breast DLBCL
Arm Type
Experimental
Arm Description
isolated breast involvement with or without nodal disease
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prophylactic intrathecal chemotherapy
Intervention Description
Prophylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
overall survival
Time Frame
From the date of treatment until the date of death from any cause (minimum 2 years)
Title
Number of patients with CNS recurrence
Time Frame
From the date of treatment until the date of CNS recurrrence (minimum 2 years)
Title
Number of patients with adverse events
Description
safety of a combined treatment of R-CHOP21 and prophylactic intrathecal chemotherapy according to the NCI-CTCAE ver.3.0
Time Frame
From the first date of treatment until 30 days after the last treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Kwak, MD, PhD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21823120
Citation
Yhim 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.
Results Reference
background
PubMed Identifier
20569446
Citation
Yhim 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.
Results Reference
background
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Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
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