An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: D'Angelo, Christopher
Contact Information:
Debbie Vidlak
dvidlak@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06047080?term=NCT06047080&rank=1#participation-criteria
Summary
Primary
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
Secondary
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in patients with IPI 3−5
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in participants classified to be high-risk based on ctDNA
To evaluate the safety of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
To characterize the glofitamab PK profile in combination with Pola-R-CHP
To evaluate the immunogenicity of glofitamab in combination with Pola-R-CHP
To evaluate the health-related quality of life (HRQoL) of participants treated with glofitamab in combination with Pola-R-CHP
Exploratory
To evaluate the health-related quality of life (HRQoL) of participants treated with glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP with respect to exploratory endpoints
To evaluate the tolerability of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
To evaluate potential relationships between drug exposure and the pharmacodynamic, efficacy, and safety of glofitamab
To evaluate potential effects of ADAs
To identify and/or evaluate biomarkers that are predictive of response to Pola-R-CHP alone or in combination with glofitamab, are early surrogates of efficacy, are associated with progression to a more severe disease state, are associated with acquired resistance, or can increase the knowledge and understanding of disease biology and drug safety
To evaluate the health status of participants treated with glofitamab in combination with Pola-R-CHP