A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT03671018
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
422 participants
INTERVENTIONAL
2018-09-25
2025-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Finding
Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.
Mosunetuzumab (IV)
Participants will receive intravenous (IV) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL
Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.
Mosunetuzumab (IV)
Participants will receive intravenous (IV) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL
2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.
Mosunetuzumab (IV)
Participants will receive intravenous (IV) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Rituximab
Participants will receive IV rituximab.
Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL
Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.
Mosunetuzumab (SC)
Participants will receive subcutaneous (SC) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL
2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.
Mosunetuzumab (SC)
Participants will receive subcutaneous (SC) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Interventions
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Mosunetuzumab (IV)
Participants will receive intravenous (IV) mosunetuzumab.
Mosunetuzumab (SC)
Participants will receive subcutaneous (SC) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
Rituximab
Participants will receive IV rituximab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed FL, DLBCL, or MCL
* Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL
* For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine
* Relapsed to prior regimen(s) after having a documented history of response (complete response \[CR\], CR unconfirmed \[CRu\], or partial response \[PR\]) of \>/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
* Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension
* Adequate hematologic, renal, and hepatic function
Exclusion Criteria
* Prior treatment with polatuzumab vedotin
* Current \> Grade 1 peripheral neuropathy
* Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (ADC) within 4 weeks before first dose of study treatment
* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
* Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
* Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration
* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration
* Prior allogeneic SCT
* Prior solid organ transplantation
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
* Current or past history of central nervous system (CNS) lymphoma or CNS disease
* History of autoimmune disease
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
New York University Langone Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin, Froedtert Hospital;Nephrology Section
Milwaukee, Wisconsin, United States
UZ Brussel
Brussels, , Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, , Belgium
Clinique St Pierre asbl
Ottignies, , Belgium
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)
Saskatoon, Saskatchewan, Canada
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital de San Pedro de Alcantara
Cáceres, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infanta Leonor; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, , Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Plymouth Hospitals NHS Trust; Pharmacy Dept
Plymouth, , United Kingdom
Countries
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References
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Budde LE, Olszewski AJ, Assouline S, Lossos IS, Diefenbach C, Kamdar M, Ghosh N, Modi D, Sabry W, Naik S, Mehta A, Nakhoda SK, Smith SD, Dorritie K, Jia T, Pham S, Huw LY, Jing J, Wu H, Ead WS, To I, Batlevi CL, Wei MC, Chavez JC. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial. Nat Med. 2024 Jan;30(1):229-239. doi: 10.1038/s41591-023-02726-5. Epub 2023 Dec 10.
Other Identifiers
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2018-001141-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO40516
Identifier Type: -
Identifier Source: org_study_id