Clinical Trial: NCT03274492
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
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
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).
Official 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
Conditions
Diffuse Large B-Cell Lymphoma
Intervention / Treatment
- Drug: Polatuzumab Vedotin
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Vincristine Placebo
- Drug: Prednisone
- Drug: Polatuzumab vedotin Placebo
Other Study ID Numbers
- GO39942
- 2017-002023-21
- 2017
Start Date (Actual)
2017-11-16
Primary Completion Date (Actual)
2026-04-30
Study Completion Date (Actual)
2026-04-30
Enrollment (Actual)
1000
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
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).
Official 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
Conditions
Diffuse Large B-Cell Lymphoma
Intervention / Treatment
- Drug: Polatuzumab Vedotin
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Vincristine Placebo
- Drug: Prednisone
- Drug: Polatuzumab vedotin Placebo
Other Study ID Numbers
- GO39942
- 2017-002023-21
- 2017
Start Date (Actual)
2017-11-16
Primary Completion Date (Actual)
2026-04-30
Study Completion Date (Actual)
2026-04-30
Enrollment (Actual)
1000
Study Type
Interventional
Phase
Phase 3