Takeda Austria GmbH

Primary Objective To evaluate the effect of vedolizumab IV on clinical response at week 14 in Chinese subjects with moderately to severely active CD. Secondary Objectives To evaluate the effect of vedolizumab IV on clinical remission at week 14. To evaluate the effect of vedolizumab IV on endoscopic response at week 14. To evaluate the effect of vedolizumab IV on clinical and endoscopic response at week 14. To evaluate the safety of vedolizumab IV treatment throughout the study period. Other Objectives Immunogenicity Objectives To evaluate the immunogenicity of vedolizumab IV treatment throughout the study period. PK Objectives To provide vedolizumab concentration data in Chinese subjects with moderately to severely active CD. If data permit, population PK analysis will be used to derive pharmacokinetic parameters (area under the plasma concentration-time curve, maximum observed plasma concentration, total clearance after IV administration, etc.).

Primary objectives After the study treatment is completed, evaluate the ORR (CR and PR) assessed by IRF according to the revised response criteria for malignant lymphoma [1]. To evaluate the safety and tolerability of the A+CHP combination. Secondary objectives After the study treatment is completed, evaluate the CR rate assessed by IRF according to the revised response criteria for malignant lymphoma. To evaluate the 1-year PFS rate assessed by IRF according to the revised response criteria for malignant lymphoma. To evaluate the 1-year OS rate. After the study treatment is completed, evaluate the ORR and CR rate, time to response (TTR), and 1-year PFS rate assessed by IRF and investigators according to the 2014 Lugano criteria. To evaluate the duration of response (DOR) assessed by investigators according to the 2014 Lugano criteria. To collect serum/plasma concentration-time data for population PK (popPK) analysis. To evaluate immunogenicity. Other objectives: To evaluate the PFS assessed by investigators. To evaluate OS.

The primary objective is to determine the objective response rate (ORR) (lasting at least 4 months) after treatment with Brentuximab in patients with CD30+ MF or pcALCL. The secondary objectives are as follows: To determine the complete response (CR) rate after Brentuximab treatment. To determine the ORR after Brentuximab treatment. To assess the duration of response after Brentuximab treatment. The safety objectives are to: Assess the safety of Brentuximab.