Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Asan Medical Center.   Recruitment status was  Recruiting

First Received on September 21, 2006.  
Last Updated on June 2, 2010  
History of Changes
This Clinical Trial Sponsored By: Asan Medical Center
Collaborator: Janssen Korea, Ltd., Korea
Information provided by: Asan Medical Center
ClinicalTrials.gov Identifier: NCT00379574
 

Purpose for Clinical Trial

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 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.

Condition Study Intervention Clinical Trial Phase
Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell
Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisolone
Drug: Lenograstim
Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone Sodium Phosphate
Prednisolone phosphate
Vincristine sulfate
Methylprednisolone Sodium Succinate
Doxorubicin
Doxorubicin hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Bortezomib

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures For Clinical Trial:

  • CR rate [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 63
Study Start Date: September 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Bortezomib + CHOP every 2 weeks 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.

Other Name: velcade

Drug: Cyclophosphamide

cyclophosphamide 750mg/m2 day 1, every 2 weeks
Other Name: cytoxan

Drug: Doxorubicin

doxorubicin 50 mg/m2 day 1, every 2 weeks
Other Name: adriamycin

Drug: Vincristine

vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
Other Name: Oncovin

Drug: Prednisolone

prednisolone 100 mg days 1-5, every 2 weeks
Other Name: Pd

Drug: Lenograstim

Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
Other Names:
  • Neutrogin
  • G-CSF

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