CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 422 target
Drug / intervention
Mosunetuzumab (IV) +4 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/NCT03671018
NCT03671018Phase 2ActiveUpdate OverdueUpdated 19mo ago · Completion was 29mo ago
Enrollment Stalled
CompareCT.gov

An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

Hoffmann-La Roche·interventional·Posted Sep 14, 2018·Updated Nov 29, 2024

In Brief

A Phase 2 clinical trial evaluating Mosunetuzumab (IV), Mosunetuzumab (SC), and 3 other interventions for B-cell Non-Hodgkin Lymphoma. Active but no longer recruiting, targeting 422 participants across 29 sites in 5 countries.

Signals

Enrollment appears stalled

Detailed Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Non-Hodgkin Lymphoma
CountriesBelgium, Canada, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2ActiveOverdue
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartSep 25, 2018
Primary CompletionJan 30, 2024
Study CompletionJul 20, 2025
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.8 years ago

Interventions

Mosunetuzumab (IV)drug

Participants will receive intravenous (IV) mosunetuzumab.

Mosunetuzumab (SC)drug

Participants will receive subcutaneous (SC) mosunetuzumab.

Polatuzumab vedotindrug

Participants will receive IV polatuzumab vedotin.

Tocilizumabdrug

Participants will receive IV tocilizumab as needed.

Rituximabdrug

Participants will receive IV rituximab.