previously untreated high-tumor burden follicular lymphoma
Conditions
Interventions
RO7030816: Participants will receive SC mosunetuzumab in a step-up dosing schedule on Day1, 8, and 15 of Cycle1, and on Day1 of Cycle 2-21.
lenalidomide: Participants will receive PO lenalidomide on D
Sponsors
Nanki Toshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the World Health Organization (WHO) 2016 classification, or classical follicular lymphoma according to the WHO 2022 classification. - FLIPI 2-5. - All Ann Arbor stages (including stage I if FLIPI 2 >=). - Must need treatment as evidenced by at least one of the following criteria: -- Bulky disease defined as: - a nodal or extranodal mass/lesion > 70 mm in its largest diameter or, - involvement of at least 3 different nodal or extranodal sites (each with a diameter greater than > 30 mm) -- Presence of at least one of the following B symptoms within the prior 6 months: - fever (> 38 deg C) of unclear etiology - night sweats - weight loss greater than 10% within the prior 6 months -- Symptomatic splenomegaly -- Symptomatic lesion: painful lesion and/or any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal) -- Any one of the following cytopenias due to lymphoma: - hemoglobin ULN or LDH > ULN (item not applicable for Germany) - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. - Adequate hepatic, hematologic, and renal function - Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants). - For women of childbearing potential (WOCBP) : must agree to abstain from becoming pregnant or breastfeeding or egg donation from 28 days before initiation of study treatment, during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustin (if applicable), 12 months after the final dose of rituximab (if applicable), and 18 months after the final dose of obinutuzumab (if applicable). - For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm or semen, as defined below: men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP/bendamustin (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the final dose of obinutuzumab (if applicable). Also, men must not have sexual intercourse with a pregnant women during the above period.
Exclusion criteria
Exclusion criteria: - Grade 3b follicular lymphoma according to the WHO 2016 classification, or follicular large B-cell lymphoma according to the WHO 2022 classification. - Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment. Please contact the Coordinating Investigator / Sponsor to discuss such cases or if there is any doubt before considering enrolment. - Prior localized radiotherapy for the FL. - Prior history of another lymphoma. - Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. - Presence or history of symptomatic or threatening lymphomatous epidural/nerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible. - Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment. - Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs) - Systemic immunosuppressive medications (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) or long-term systemic corticosteroid use within 10 days prior to the first dose of the investigational product. - Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months after the final dose of study treatment. - Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent. - Seropositive for or active viral infection with Hepatitis B virus (HBV) - Known seropositive for, or active infection hepatitis C virus (HCV) - Known or suspected hypersensitivity to biopharmaceuticals produced in Chinese hamster ovarian (CHO) cells or any component of the mosunetuzumab, Anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the excipients. - History of solid organ transplantation or allogeneic stem cell transplant (SCT). - Active autoimmune disease requiring treatment. - History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, uveitis or glomerulonephritis. - Participants with any active infection such as known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds), known or suspected chronic active Epstein-Barr virus (EBV) infection, are excluded. - History of confirmed progressive multifocal leukoencephalopathy (PML). - Known or suspected history of hemophagocytic lymphohistiocytosis (HLH). - History of erythema multiforme, Grade >= 3 rash, or blistering rash following prior treatment with immunomodulatory derivatives. - History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis. - Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease and therapy for >= 3 years. - Presence or history of CNS or meningeal involvement by lymphoma. - Pregnant, planning to become pregnant or lactating. - Any significant medical condit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Lugano 2014 Response Criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, confirmatory, exploratory, phamacokinetics, phamacodynamics NCI CTCAE v5.0, ASTCT Grading system | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed