A phase III study of RO7030816(mosunetuzumab) in patients with follicular lymphoma after at least one line of systemic therapy

JRCT ID: jRCT2041210051

Registered date:06/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY
• Date of first enrollment: 28/10/2021
• Target sample size: 400
• Countries of recruitment: Australia,Japan,China,Japan,Germany,Japan,Republic of Korea,Japan,Poland,Japan,Taiwan,Japan,Turkey,Japan,Ukraine,Japan,United Kingdom,Japan,United States,Japan,France,Japan,Spain,Japan,Brazil,Japan,Italy,Japan,Russian Federation,Japan
• Study type: Interventional

Intervention(s)

mosunetuzumab: Participants will receive IV mosunetuzumab in a step-up dosing schedule on Day 1, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2-12.
lenalidomide: 20 mg as an oral administration
rituximab: 375 mg/m2 as an IV infusion
tocilizumab: 8 mg/kg as an IV infusion

Outcome(s)

Primary Outcome

Efficacy
Lugano 2014 Response Criteria

Secondary Outcome

Safety, Efficacy, Confirmatory, Exploratory, Phamacokinetics, Phamacodynamics, Phamacogenomics, Other
NCI CTCAE v5.0, ASTCT Grading system

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Any history of Grade 3b FL
-Any history of disease transformation and/or diffuse-large B cell lymphoma
-Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
- Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.
-Active or history of CNS lymphoma or leptomeningeal infiltration
-Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade </= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) prior to Day 1 of Cycle 1
-Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
-History of solid organ transplantation
-History of erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
-History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
-Known or suspected chronic active Epstein-Barr virus (EBV) infection
-Known or suspected history of hemophagocytic lymphohistiocytosis
-Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
-History of progressive multifocal leukoencephalopathy (PML)
-Administration of 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
-Other malignancy that could affect compliance with the protocol or interpretation of results
-Active autoimmune disease requiring treatment
-History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis.
-Prior allogeneic stem cell transplantation
-Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, 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) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
-Pregnant or lactating or intending to become pregnant during the study
-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Exclude criteria

- Any history of Grade 3b FL
- Any history of disease transformation and/or diffuse-large B cell lymphoma
- Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
- Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.
- Active or history of CNS lymphoma or leptomeningeal infiltration
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade </= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) prior to Day 1 of Cycle 1
- Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
- History of solid organ transplantation
- History of erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
- History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
- Known or suspected chronic active Epstein-Barr virus (EBV) infection
- Known or suspected history of hemophagocytic lymphohistiocytosis
- Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- History of progressive multifocal leukoencephalopathy (PML)
- Administration of 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
- Other malignancy that could affect compliance with the protocol or interpretation of results
- Active autoimmune disease requiring treatment
- History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis
- Prior allogeneic stem cell transplantation
- Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, 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) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- Pregnant or lactating or intending to become pregnant during the study
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Related Information

• Primary Sponsor: Enkhee Purev
• Secondary ID(s): NCT04712097