6 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. Secondly the incidence of parastomal hernias will be recorded and complications caused by preventive mesh placement…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
Primary Objective: To study whether nocturnal symptoms of CTS depend on wrist position and, if so, on which position. Identifying which wrist position aggravates CTS could help design a more effective splint. Secondary Objective: To study whether…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…