Non Hodgkin Lymphoma Clinical Trial

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

ECOG PS of 0, 1, or 2
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

Key Exclusion Criteria:

Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

422

Study ID:

NCT03671018

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 29 Locations for this study

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University of Alabama at Birmingham School of Medicine
Birmingham Alabama, 35249, United States
City of Hope
Duarte California, 91010, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
University of Miami Miller School of Medicine
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Michigan Hospital
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
New York University Langone Medical Center
New York New York, 10016, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Lifespan Cancer Institute
Providence Rhode Island, 02905, United States
University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College of Wisconsin, Froedtert Hospital;Nephrology Section
Milwaukee Wisconsin, 53226, United States
UZ Brussel
Brussel , 1090, Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul , 7100, Belgium
Clinique St Pierre asbl
Ottignies , 1340, Belgium
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)
Saskatoon Saskatchewan, S7N 4, Canada
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital de San Pedro de Alcantara
Caceres , 10003, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Infanta Leonor; Servicio de Hematologia
Madrid , 28031, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla , 41009, Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 0, United Kingdom
Plymouth Hospitals NHS Trust; Pharmacy Dept
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

422

Study ID:

NCT03671018

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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