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

NCT01448096 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-08-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Consortium for Improving Survival of Lymphoma

    collaborator OTHER

  • Chonbuk National University Hospital

    lead OTHER

Principal Investigators

  • Jae-Yong Kwak, MD, PhD · Chonbuk National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2019-07-10
Completion
2019-07-10

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448096 on ClinicalTrials.gov