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

NCT01448096 | Completed Phase 2

• 1 other identifier: Chonbuk058
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Large B Cell Diffuse Lymphoma

Keywords

primary breast diffuse large B cell lymphoma; rituximab; prophylactic intrathecal chemotherapy; CNS recurrence

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  From the date of treatment until the date of disease progression or death from any cause (minimum 2 years)

Secondary Outcomes (3)

• overall survival

  From the date of treatment until the date of death from any cause (minimum 2 years)

• Number of patients with CNS recurrence

  From the date of treatment until the date of CNS recurrrence (minimum 2 years)

• Number of patients with adverse events

  From the first date of treatment until 30 days after the last treatment

Study Arms (1)

primary breast DLBCL

EXPERIMENTAL

isolated breast involvement with or without nodal disease

Drug: Rituximab; Procedure: Prophylactic intrathecal chemotherapy

Interventions

Rituximab DRUG

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.

primary breast DLBCL

Prophylactic intrathecal chemotherapy PROCEDURE

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

primary breast DLBCL

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• Consortium for Improving Survival of Lymphoma: collaborator

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Related Publications (2)

• 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.

  PMID: 21823120 BACKGROUND

• 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.

  PMID: 20569446 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jae-Yong Kwak, MD, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 7, 2011
• Study Start: August 1, 2011
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

KR (1)