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

Launched by UNIVERSITY OF WASHINGTON · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called mosunetuzumab to see how safe and effective it is for treating patients with certain types of slow-growing B-cell lymphoma, including follicular and marginal zone lymphomas. These are types of cancer that are generally less aggressive and often do not require immediate treatment. Participants in the trial must be at least 18 years old, have a confirmed diagnosis of indolent B-cell lymphoma, and have not received any prior treatment for their lymphoma. They should also have low levels of disease and meet specific health criteria.

If eligible, participants will receive low doses of mosunetuzumab, which is designed to help the body's immune system fight the cancer by targeting the tumor cells. Throughout the trial, patients will be monitored for any side effects and the overall effectiveness of the treatment. It’s important to note that women who can become pregnant will need to take precautions to avoid pregnancy during the study. This trial is currently recruiting participants, and those who join will play a valuable role in helping researchers understand how this treatment works.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • 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