This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Stanford Cancer Institute Inpatient Investigational Pharmacy
Stanford, California, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Westchester
East White Plains, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
...and 10 more locations
End of Treatment Complete Response (EOT CR) Rate
Time frame: Up to approximately 24 months
Overall Response Rate (ORR) at the EOT
Time frame: Up to approximately 24 months
Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 90 days after the final dose of study treatment
Serum Concentration of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
Maximum Concentration (Cmax) of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
Total Exposure (AUC) of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
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