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

NCT03677141 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-12-18

Study results available
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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).

Conditions

  • B-cell Non-Hodgkin Lymphoma

Interventions

DRUG

Mosunetuzumab

Participants will receive intravenous (IV) mosunetuzumab.

DRUG

Polatuzumab Vedotin

Participants will receive polatuzumab vedotin via IV.

DRUG

Rituxumab

Participants will receive rituxumab via IV.

DRUG

Cyclophosphamide

Participants will receive cyclophosphamide via IV.

DRUG

Doxorubicin

Participants will receive doxorubicin via IV.

DRUG

Vincristine

Participants will receive vincristine via IV.

DRUG

Prednisone

Participants will receive oral prednisone.

DRUG

Tocilizumab

Participants will receive tocilizumab via IV.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2023-10-12
Completion
2023-10-12
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677141 on ClinicalTrials.gov