Comparing Mosunetuzumab with Rituximab for nodular lymphocyte predominant b-cell lymphoma

Exclusion

• −History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab.
• −Classical Hodgkin lymphoma (cHL) or composite lymphoma.
• −Active transformed NLPHL, concerns of the treating physician of an active occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy. Participants with a history of transformed NLPHL in complete remission for at least 2 years since completion of cytotoxic therapy are eligible
• −NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy.
• −Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
• −Patients who are receiving any other investigational agents.
• −Patients with central nervous system (CNS) involvement as a result of lymphoma.
• −Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocolProtocolThe detailed plan a study must follow.Read more → unreasonably hazardous.
• −Prior allogeneic stem cell or solid organ transplantation.
• −Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist \[registered trademark\]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.
• −Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, including, but not limited to:
• −Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina).
• −Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
• −Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
• −Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
• −Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohortCohortA group of participants sharing a characteristic, followed together.Read more →.
• −History of confirmed progressive multifocal leukoencephalopathy (PML).
• −Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
• −Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment.
• −Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.
• −Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
• −Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study.
• −Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment.