Status:
COMPLETED
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Janssen Korea, Ltd., Korea
Conditions:
Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the clinical results have been improved with new drugs and new modalities such as cyclophosphamide, doxorubicin, vinc...
Detailed Description
Intended number of patients: 63 patients in total * Phase I: 9 patients for 3 levels * Phase II: 50 patients plus 3 patient from Phase I at MTD level * Plus 4 patients: considering 5% follow-up loss ...
Eligibility Criteria
Inclusion
- Histologically confirmed DLBCL
- Age 70 years or less
- Previously untreated
- Performance status: ECOG 0-2
- Advanced stage: stage III, IV, or non-contiguous stage II
- Measurable disease: 1 cm or more by spiral CT
- Normal liver function
Exclusion
- Platelet count less than 75,000/microL within 14 days before enrollment.
- Absolute neutrophil count of less than 1,500/microlL within 14 days before enrollment.
- Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than 50 mL/min within 14 days before enrollment.
- Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment.
- Hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding.
- Other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00379574
Start Date
September 1 2006
End Date
January 1 2011
Last Update
March 15 2013
Active Locations (2)
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1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea, 138-736
2
Asan Medical Cener
Seoul, South Korea