At a glance
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A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas
In Brief
A Phase 2 clinical trial evaluating Bortezomib, Cyclophosphamide, and 4 other interventions for Lymphoma, Large-Cell, Diffuse and Lymphoma, B-Cell. Completed, enrolled 49 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
cyclophosphamide 750mg/m2 day 1, every 2 weeks
doxorubicin 50 mg/m2 day 1, every 2 weeks
vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
prednisolone 100 mg days 1-5, every 2 weeks
Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks