A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Summary
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.
Arms & interventions
- DrugObinutuzumab
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
- DrugGlofitamab
Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).
- DrugGemcitabine
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
- DrugOxaliplatin
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Outcome measures
Primary
Incidence of cytokine release syndrome (CRS)
Time frame: Up to approximately 5 years
Secondary
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
Time frame: Up to approximately 5 years
Overall response rate (ORR) as determined by IRF and the investigator
Time frame: Up to approximately 5 years
Duration of response (DOR)
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)
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
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)
Time frame: From enrollment to date of death from any cause (Up to approximately 5 years)
Eligibility criteria
Study locations (33)
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508
Community Cancer Institute (CCI)
Clovis, California, 93611
Providence Medical Foundation
Fullerton, California, 92835
Los Angeles Cancer Network
Glendale, California, 91204
Valkyrie Clinical Trials
Los Angeles, California, 90067
Valkyrie Clinical Trials
Panorama City, California, 91402
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, 90502-2006
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
North Florida/ South Georgia VA Medical Center
Gainesville, Florida, 32608
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
Orlando Health Cancer Institute
Orlando, Florida, 32806
St Luke?s Cancer Institute
Boise, Idaho, 83712
Cancer Care Specialists of Central Illinois
Swansea, Illinois, 62226
Mission Blood and Cancer - MercyOne Cancer Center
Waukee, Iowa, 50263
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, 70809
Boston Medical Center
Boston, Massachusetts, 02118
Corewell Health
Grand Rapids, Michigan, 49503
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
New York Oncology Hematology, P.C.
Albany, New York, 12206
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
Oncology Associates of Oregon, P.C
Eugene, Oregon, 97401
Providence Portland Medical Center
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Tennessee Oncology
Chattanooga, Tennessee, 37403
Tennessee Oncology
Nashville, Tennessee, 37203
Baylor Scott & White Health
Temple, Texas, 76502
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Texas Oncology- Northeast Texas
Tyler, Texas, 75702
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, 23456
Northwest Medical Specialties
Tacoma, Washington, 98405