Finding studies
Finding studies
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Lead
Deepa Jagadeesh
With
This study is a multi-institution, open-label, phase I/II study designed to evaluate the safety and efficacy of R-CHOP + ME-401 for participants with newly diagnosed DLBCL. Objectives for the phase I portion of this study are as follows: Primary objectives: * To determine the recommended phase 2 dose (RP2D) of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL. * To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL. Objectives for the phase II portion of this study are as follows: * To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL, as measured by 1 year PFS rate * To estimate the response rates (complete and partial remission),duration of response (DOR), time to progression (TTP), and overall survival (OS) with ME-401 plus R-CHOP. * To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
