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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


Phase 2
20 Years
70 Years
Open (Enrolling)
Female
Large B Cell Diffuse Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jae-Yong Kwak, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonbuk National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

Chonbuk058

NCT ID:

NCT01448096

Start Date:

August 2011

Completion Date:

December 2018

Related Keywords:

  • Large B Cell Diffuse Lymphoma
  • primary breast diffuse large B cell lymphoma
  • rituximab
  • prophylactic intrathecal chemotherapy
  • CNS recurrence
  • Primary breast diffuse large B cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse

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