A Phase III randomized, open-label, international, multicenter study evaluating the efficacy and safety of mosunetuzumab plus lenalidomide in comparison to CD20 Ab plus chemotherapy in subjects with previously untreated high-tumor burden follicular lympho
An Open-Label Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination with Lenalidomide in Participants with Previously Untreated FLIPI 2-5 Follicular Lymphoma
Nanki Toshihiro
Division of Connective Tissue Disease, Department of Internal Medicine, Toho University School of Medicine, Toho University
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
+81-120-189-706
clinical-trials@chugai-pharm.co.jp
Clinical trials information
Chugai Pharmaceutical Co., Ltd.
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
+81-120-189-706
clinical-trials@chugai-pharm.co.jp
Recruiting
July. 05, 2024
Nov. 25, 2024
71
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
- 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 >=).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate hepatic, hematologic, and renal function
- 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), 6 months after the final dose of chemotherapies (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 chemotherapies (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.
- 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.
- Prior localized radiotherapy for the FL.
- Prior history of another lymphoma.
- Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment within 48 hours.
- Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure.
- Symptomatic lymphomatous epidural lesion.
- Use of any standard or experimental anti-cancer drug therapy within 42 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 (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) or corticosteroid > 1mg/kg/day prednisone or equivalent within 10 days prior to first dose of study treatment.
- 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, 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.
- Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results.
- 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 for >= 3 years.
- Presence or history of CNS or meningeal involvement by lymphoma.
- Pregnant, planning to become pregnant or lactating.
- Any significant medical conditions.
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 Day1-21 of Cycle 2-12.
rituximab: Participants will receive IV rituximab on Day1 of each cycle.
obinutuzumab: Participants will receive IV obinutuzumab on Day1, 8, and 15 of Cycle1, and on Day1 of Cycle2-18 or 20.
cyclophosphamide: Participants will receive IV cyclophosphamide on Day1 of each cycle.
doxorubicin: Participants will receive IV doxorubicin on Day1 of each cycle.
vincristine: Participants will receive IV vincristine on Day1 of each cycle.
prednisolone: Participants will receive PO or IV prednisolone on Day1-5 of each cycle.
bendamustine: Participants will receive IV bendamustine on Day1-2 of each cycle.
tocilizumab: 8mg/kg as an IV infusion.
Hokkaido University Hospital Institutional Review Board
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
+81-11-706-7061
tiken@med.hokudai.ac.jp
Approval
May. 28, 2024
Yes
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
