Non Hodgkin Lymphoma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for Phase Ib and Phase II Portions

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

Inclusion Criteria for Phase Ib Portion

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

Inclusion Criteria for Phase II Portion

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

Exclusion Criteria for Phase Ib Portion

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)

Exclusion Criteria for Phase II Portion

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT03677141

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 40 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 35233, United States
University of California; Moores Cancer Center
La Jolla California, 92093, United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Santa Monica California, 90404, United States
Banner MD Anderson Cancer Center
Greeley Colorado, 85234, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
University of Miami Miller School of Medicine
Miami Florida, 33136, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Scott and White Hospital; Cancer Center
Temple Texas, 76508, United States
Medical College of Wisconsin, Inc.
Milwaukee Wisconsin, 53226, United States
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
Salzburg , 5020, Austria
LKH Steyr
Steyr , 4400, Austria
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
Wien , 1090, Austria
Hanusch-Krankenhaus
Wien , 1140, Austria
CHU Henri Mondor; Service d'Oncologie Medicale
Creteil , 94010, France
Centre Leon Berard
Lyon , 69008, France
Hôpital Saint-Louis
Paris , 75475, France
Centre Henri Becquerel- Centre de Lutte Contre le Cancer
Saint Herblain , 44805, France
Gustave Roussy
Villejuif CEDEX , 94800, France
Pusan National University Yangsan Hospital
Gyeongsangnam-do , 50612, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Maria Sklodowska-Curie Memorial Cancer Centre
Gliwice , 44-10, Poland
Małopolskie Centrum Medyczne
Kraków , 31-50, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Slupsk , 76-20, Poland
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
Warsaw , 02-77, Poland
Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku
Wrocław , , Poland
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario Virgen Macarena
Seville Sevilla, 41071, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital San Pedro de Alcantara; Servicio de Hematología
Caceres , 10003, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT03677141

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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