This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
RECRUITINGCommunity Cancer Institute (CCI)
Clovis, California, United States
RECRUITINGProvidence Medical Foundation
Fullerton, California, United States
RECRUITINGLos Angeles Cancer Network
Glendale, California, United States
Incidence of cytokine release syndrome (CRS)
Time frame: Up to approximately 5 years
Incidence of serious cytokine release syndrome (CRS) events
Time frame: Up to approximately 5 years
CRS frequency relative to the start of glofitamab infusions
Time frame: Up to approximately 5 years
Complete response (CR) rate as determined by independent review facility (IRF) and the investigator
CR rate is defined as the proportion of participants whose best overall response is a CR based on PET/CT according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Time frame: Up to approximately 5 years
Overall response rate (ORR) as determined by IRF and the investigator
ORR is defined as the proportion of participants whose best overall response is a PR or a CR according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Time frame: Up to approximately 5 years
Duration of response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first.
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Duration of complete response (DOCR)
DOCR is defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first.
Time frame: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Progression-free survival (PFS) as determined by the IRF and the investigator
PFS is defined as the time from enrollment to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the Independent Review Facility and investigator.
Time frame: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Overall survival (OS)
OS is defined as the time from enrollment to date of death from any cause.
Time frame: From enrollment to date of death from any cause (Up to approximately 5 years)
Reference Study ID Number: GO45434 https://forpatients.roche.com/
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Valkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGZuckerberg San Francisco General Hospital
San Francisco, California, United States
RECRUITINGThe Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, United States
RECRUITINGRocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
RECRUITINGNorth Florida/ South Georgia VA Medical Center
Gainesville, Florida, United States
RECRUITINGMount Sinai Comprehensive Cancer Center
Miami, Florida, United States
RECRUITING...and 41 more locations