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Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

NCT00379574 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-03-15

Study results available
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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.

Conditions

  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, B-Cell

Interventions

DRUG

Bortezomib

Bortezomib: For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks. For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.

DRUG

Cyclophosphamide

cyclophosphamide 750mg/m2 day 1, every 2 weeks

DRUG

Doxorubicin

doxorubicin 50 mg/m2 day 1, every 2 weeks

DRUG

Vincristine

vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks

DRUG

Prednisolone

prednisolone 100 mg days 1-5, every 2 weeks

DRUG

Lenograstim

Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Cheolwon Suh, M.D.,Ph.D. · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

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 NCT00379574 on ClinicalTrials.gov