The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Participants will receive intravenous (IV) glofitamab for up to 3 cycles.
Participants will receive IV obinutuzumab on Cycle 1 Day 1.
Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.
Participants will receive up to 2 doses of IV rituximab.
Participants will receive IV ifosfamide for up to 3 cycles.
Participants will receive IV carboplatin for up to 3 cycles.
Participants will receive IV etoposide for up to 3 cycles.
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
New York University Langone Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria
Time frame: Up to 2.5 years
Event-free survival (EFS) after enrollment
Time frame: From enrollment to the first occurrence of disease progression, initiation of new anti-lymphoma therapy (not including planned ASCT or CAR-T therapy), or death from any cause (whichever occurs first) (up to 2.5 years)
Progression-free survival (PFS) after enrollment
Time frame: From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)
Mobilization-adjusted response rate (MARR)
The proportion of participants treated with intent to proceed to ASCT that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria, and additionally achieves mobilization of a minimum of 2,000,000 CD34+ hematopoietic stem cells/kg for ASCT
Time frame: Up to 2.5 years
Overall survival (OS) after enrollment
Time frame: From enrollment to death from any cause (up to 2.5 years)
CR rate after enrollment, defined as the proportion of participants that achieves a CR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria
Time frame: Up to 2.5 years
Duration of Response (DOR)
Time frame: From the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)
Duration of complete response (DOCR)
Time frame: From the first occurrence of a documented complete response to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)
Percentage of participants with adverse events (AEs)
Time frame: Up to 2.5 years
Percentage of participants with cytokine release syndrome (CRS)
Time frame: Up to 2.5 years
Maximum serum concentration (Cmax) of glofitamab
Time frame: Up to 2.5 years
Minimum serum concentration (Cmin) of glofitamab
Time frame: Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
Time frame: From baseline up to 2.5 years
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