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
Completed · Phase 1/Phase 2
Conditions studied: B-cell Non-Hodgkin Lymphoma
In brief
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).
Key facts
- Study ID
- NCT03677141
- Run by
- Hoffmann-La Roche
- People needed
- 117
- Starts
- 2019-03-08
- Expected to finish
- 2023-10-12
- Last updated by the study team
- 2024-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- University of California; Moores Cancer Center — La Jolla, California, United States
- University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica — Santa Monica, California, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic Cancer Center — Rochester, Minnesota, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Scott and White Hospital; Cancer Center — Temple, Texas, United States
- Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States
- Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU — Salzburg, Austria
- LKH Steyr — Steyr, Austria
- Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria
- Hanusch-Krankenhaus — Vienna, Austria
- CHU Henri Mondor; Service d'Oncologie Medicale — Créteil, France
- Centre Leon Berard — Lyon, France
- Hôpital Saint-Louis — Paris, France
- Centre Henri Becquerel- Centre de Lutte Contre le Cancer — Saint-Herblain, France
- Gustave Roussy — Villejuif, France
- Maria Sklodowska-Curie Memorial Cancer Centre — Gliwice, Poland
Full record on ClinicalTrials.gov
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