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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

NCT ID: NCT03677141

Last Updated: 2024-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-08

Study Completion Date

2023-10-12

Brief Summary

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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).

Detailed Description

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Conditions

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B-cell Non-Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding

Participants will receive M-CHOP up to the phase II recommended dose (RP2D).

Group Type EXPERIMENTAL

Mosunetuzumab

Intervention Type DRUG

Participants will receive intravenous (IV) mosunetuzumab.

Polatuzumab Vedotin

Intervention Type DRUG

Participants will receive polatuzumab vedotin via IV.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Vincristine

Intervention Type DRUG

Participants will receive vincristine via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Tocilizumab

Intervention Type DRUG

Participants will receive tocilizumab via IV.

Phase Ib: M-CHP-Pola Dose-Finding

Participants will receive M-CHP-Pola up to the RP2D.

Group Type EXPERIMENTAL

Mosunetuzumab

Intervention Type DRUG

Participants will receive intravenous (IV) mosunetuzumab.

Polatuzumab Vedotin

Intervention Type DRUG

Participants will receive polatuzumab vedotin via IV.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Tocilizumab

Intervention Type DRUG

Participants will receive tocilizumab via IV.

Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort

Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.

Group Type EXPERIMENTAL

Mosunetuzumab

Intervention Type DRUG

Participants will receive intravenous (IV) mosunetuzumab.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Vincristine

Intervention Type DRUG

Participants will receive vincristine via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Tocilizumab

Intervention Type DRUG

Participants will receive tocilizumab via IV.

Phase II: M-CHP-Pola 1L DLBCL

Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.

Group Type EXPERIMENTAL

Mosunetuzumab

Intervention Type DRUG

Participants will receive intravenous (IV) mosunetuzumab.

Polatuzumab Vedotin

Intervention Type DRUG

Participants will receive polatuzumab vedotin via IV.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Tocilizumab

Intervention Type DRUG

Participants will receive tocilizumab via IV.

Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL

Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.

Group Type ACTIVE_COMPARATOR

Polatuzumab Vedotin

Intervention Type DRUG

Participants will receive polatuzumab vedotin via IV.

Rituxumab

Intervention Type DRUG

Participants will receive rituxumab via IV.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Phase II: M-CHOP 1L DLBCL

Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.

NOTE: No participants were enrolled to this arm.

Group Type EXPERIMENTAL

Mosunetuzumab

Intervention Type DRUG

Participants will receive intravenous (IV) mosunetuzumab.

Cyclophosphamide

Intervention Type DRUG

Participants will receive cyclophosphamide via IV.

Doxorubicin

Intervention Type DRUG

Participants will receive doxorubicin via IV.

Vincristine

Intervention Type DRUG

Participants will receive vincristine via IV.

Prednisone

Intervention Type DRUG

Participants will receive oral prednisone.

Tocilizumab

Intervention Type DRUG

Participants will receive tocilizumab via IV.

Interventions

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Mosunetuzumab

Participants will receive intravenous (IV) mosunetuzumab.

Intervention Type DRUG

Polatuzumab Vedotin

Participants will receive polatuzumab vedotin via IV.

Intervention Type DRUG

Rituxumab

Participants will receive rituxumab via IV.

Intervention Type DRUG

Cyclophosphamide

Participants will receive cyclophosphamide via IV.

Intervention Type DRUG

Doxorubicin

Participants will receive doxorubicin via IV.

Intervention Type DRUG

Vincristine

Participants will receive vincristine via IV.

Intervention Type DRUG

Prednisone

Participants will receive oral prednisone.

Intervention Type DRUG

Tocilizumab

Participants will receive tocilizumab via IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
* Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
* Adequate hematologic function


Participants must also meet the following criteria for study entry into the Phase Ib portion:

* Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
* Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
* Treatment with at least one prior CD20-directed therapy
* Group B only: no prior treatment with polatuzumab vedotin


Participants must also meet the following criteria for study entry in the Phase II portion:

* Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
* International Prognostic Index (IPI) score of 2-5

Exclusion Criteria

* Prior treatment with mosunetuzumab
* Prior allogenic stem-cell transplant
* Current Grade \>1 peripheral neuropathy
* Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
* Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
* Prior solid organ transplantation
* History of autoimmune disease
* Current or past history of central nervous system (CNS) lymphoma
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Significant cardiovascular disease or pulmonary disease
* Clinically significant history of liver disease
* Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis


Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:

* Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
* Prior treatment with radiotherapy within 2 weeks prior to C1D1
* Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
* Prior treatment with \>250 mg/m\^2 doxorubicin (or equivalent anthracycline dose)


Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:

* Participants with transformed lymphoma
* Prior therapy for B-cell NHL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

University of California; Moores Cancer Center

La Jolla, California, United States

Site Status

University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

Santa Monica, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Scott and White Hospital; Cancer Center

Temple, Texas, United States

Site Status

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Site Status

Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

Salzburg, , Austria

Site Status

LKH Steyr

Steyr, , Austria

Site Status

Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

Site Status

Hanusch-Krankenhaus

Vienna, , Austria

Site Status

CHU Henri Mondor; Service d'Oncologie Medicale

Créteil, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

Centre Henri Becquerel- Centre de Lutte Contre le Cancer

Saint-Herblain, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Maria Sklodowska-Curie Memorial Cancer Centre

Gliwice, , Poland

Site Status

Ma?opolskie Centrum Medyczne

Krakow, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, , Poland

Site Status

Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych

Warsaw, , Poland

Site Status

Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku

Wroc?aw, , Poland

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital San Pedro de Alcantara; Servicio de Hematología

Cáceres, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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United States Austria France Poland South Korea Spain

References

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Westin J, Phillips TJ, Mehta A, Hoffmann MS, Gonzalez-Barca E, Thieblemont C, Bastos-Oreiro M, Greil R, Giebel S, Wei MC, Wang J, Bucher R, Sit J, Penuel E, Purev E, Yee DL, Bergua-Burgues JM. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study. Blood Adv. 2025 May 27;9(10):2461-2472. doi: 10.1182/bloodadvances.2024014907.

Reference Type DERIVED
PMID: 39908481 (View on PubMed)

Olszewski AJ, Phillips TJ, Hoffmann MS, Armand P, Kim TM, Yoon DH, Mehta A, Greil R, Westin J, Lossos IS, Munoz JL, Sit J, Wei MC, Yang A, Chen V, Purev E, Yee DL, Jaeger U. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study. Blood Adv. 2023 Oct 24;7(20):6055-6065. doi: 10.1182/bloodadvances.2023010840.

Reference Type DERIVED
PMID: 37581593 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018-001039-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO40515

Identifier Type: -

Identifier Source: org_study_id