Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response (OR)
研究概览
简要总结
This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
详细描述
OUTLINE:
Patients receive mosunetuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) on study. Patients may undergo CT and/or magnetic resonance imaging (MRI) as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
After completion of study treatment, patients are followed up at week 13, at 6 months, and then for up to 5 years per institutional standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at time of signing informed consent
- •Capable of understanding and providing written informed consent
- •Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
- •Follicular lymphoma (grade 1-2 or 3A)
- •Marginal zone lymphoma
- •Ann Arbor stage II-IV disease
- •No prior therapy for lymphoma
- •Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
- •Nodal or extranodal tumor mass < 7 cm
- •Involvement of less than 3 nodal sites with a diameter > 3 cm
- •No systemic or B symptoms
- •No splenomegaly > 16 cm by imaging
- •No local risk of vital organ compression
- •No pleural or peritoneal serous effusions
- •No leukemic phase (> 5,0000/ uL circulating lymphocytes)
- •No significant cytopenias defined as platelets < 100,000/uL, hemoglobin < 10 g/dL, or absolute neutrophil count (ANC) < 1500/ uL
- •Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
- •Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
- •Aspartate aminotransferase (AST) ≤ 3 x the ULN
- •Alanine aminotransferase (ALT) ≤ 3 x the ULN
- •Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
- •Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
- •Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab
排除标准
- •History of severe allergic reaction to monoclonal antibody therapy
- •History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
- •Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
- •Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
- •Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbBsAg] serology):
- •Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
- •Autoimmune disease requiring active therapy
- •History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- •Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
- •Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
- •Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
- •Prior solid organ transplantation
- •Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab
研究组 & 干预措施
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Questionnaire Administration (Other)
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Biospecimen Collection (Procedure)
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Computed Tomography (Procedure)
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Mosunetuzumab (Biological)
Treatment (mosunetuzumab)
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Overall response (OR)
时间窗: Up to week 13
OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.
次要结局
- Time to next lymphoma treatment(At initiation of study treatment to initiation of next therapy, up to 5 years)
- Incidence of Immune Effector Cell Associated Neurotoxicity syndrome(Up to 30 days after last dose of study treatment)
- Progression free survival (PFS)(At initiation of study treatment to disease progression, up to 5 years)
- Duration of response(Up to 5 years)
- Incidence of grade 3 or greater cytokine release syndrome (CRS)(Up to 30 days after last dose of study treatment)
- Incidence of adverse events (AE's)(Up to 30 days after last dose of study treatment)
- Time to cytotoxic treatment(At initiation of study treatment to initiation of cytotoxic treatment, up to 5 years)