Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib is well known to be effective for multiple myeloma and has been being tried for other malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every 2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Janssen Korea, Ltd., Korea
• Treatments: Bortezomib; Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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