CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Mosunetuzumab +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03677141
NCT03677141Phase 2Completed
CompareCT.gov

A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

Hoffmann-La Roche·interventional·Posted Sep 19, 2018·Updated Dec 18, 2024

In Brief

A Phase 2 clinical trial evaluating Mosunetuzumab, Polatuzumab Vedotin, and 6 other interventions for B-cell Non-Hodgkin Lymphoma. Completed, enrolled 117 participants across 41 sites in 6 countries.

Detailed Summary

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Non-Hodgkin Lymphoma
CountriesAustria, France, Poland, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartMar 8, 2019
Primary CompletionOct 12, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 7.8 years ago

Interventions

Mosunetuzumabdrug

Participants will receive intravenous (IV) mosunetuzumab.

Polatuzumab Vedotindrug

Participants will receive polatuzumab vedotin via IV.

Rituxumabdrug

Participants will receive rituxumab via IV.

Cyclophosphamidedrug

Participants will receive cyclophosphamide via IV.

Doxorubicindrug

Participants will receive doxorubicin via IV.

Vincristinedrug

Participants will receive vincristine via IV.

Prednisonedrug

Participants will receive oral prednisone.

Tocilizumabdrug

Participants will receive tocilizumab via IV.