Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

Inclusion Criteria

• •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