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Clinical Trial

Efficacy of Large B-Cell Lymphoma Treatments

Study Description

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Polatuzumab Vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Drug - Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Drug - Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Drug - Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Drug - Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Drug - Vincristine Placebo

Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

Drug - Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

Drug - Polatuzumab vedotin Placebo

Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Additional Information

Official Study Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Clinical Trial ID

NCT03274492

ParticipAid ID

0dNwLe