Lymphoma, Large B-Cell, Diffuse Clinical Trial
Official title:
An Open Label Multicenter Phase Ib/II Trial to Determine the Dose of BI 836826 in Combination With Gemcitabine and Oxaliplatin (GemOx) and the Efficacy of BI 836826-GemOx Versus Rituximab (R)- GemOx (R-GemOx) in Patients With Relapsed/ Refractory Diffuse Large B-cell Lymphoma (DLBCL) Who Are Not Eligible for, or Have Relapsed/Progressed After Autologous/Allogeneic Stem Cell Transplant
Part 1 (Phase Ib)
Primary objective:
To establish the maximum tolerated dose (MTD) of BI 836826 in combination with GemOx.
Secondary objectives:
To evaluate pharmacokinetics of BI 836826 when given in combination with GemOx and to
investigate preliminary efficacy in terms of the overall response rate based on
investigator's assessment.
Part 2 (Phase II randomized)
Primary objective:
To investigate the efficacy by means of the overall response rate (PR+ CR) based on central
review assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to
R-GemOx.
Secondary objective:
To investigate the efficacy by means of the complete remission rate based on central review
assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to Rituximab
+ gemcitabine + oxaliplatin (RGemOx).
n/a
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