A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT06806033
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-03-05
2029-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R/R Aggressive B-Cell Non-Hodgkin's Lymphoma
Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.
Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
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).
Gemcitabine
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
Oxaliplatin
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Interventions
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Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
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).
Gemcitabine
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
Oxaliplatin
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Eligibility Criteria
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Inclusion Criteria
* R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy
* At least one line of prior systemic therapy
* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
* At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on CT scan
* Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
* According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting
* Adequate hematologic and renal function
Exclusion Criteria
* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
* Any history of Waldenstrom's macroglobulinemia
* Primary mediastinal B-cell lymphoma
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
* Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
* Prior treatment with gemcitabine or oxaliplatin
* Peripheral neuropathy or paresthesia assessed to be Grade \>/= 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
* Primary or secondary CNS lymphoma at the time of recruitment
* Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible
* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* History of other primary malignancy, with exceptions defined by the protocol
* Significant or extensive cardiovascular disease
* Significant pulmonary disease (including moderate or severe obstructive pulmonary disease)
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
* Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy
* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
* Prior solid organ transplantation or prior allogenic stem cell transplant
* Active autoimmune disease requiring treatment
* Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency
* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
* Clinically significant history of cirrhotic liver disease
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
Providence Medical Foundation
Fullerton, California, United States
Los Angeles Cancer Network
Glendale, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
North Florida/ South Georgia VA Medical Center
Gainesville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
St Luke?s Cancer Institute
Boise, Idaho, United States
Cancer Care Specialists of Central Illinois
Swansea, Illinois, United States
Mission Blood and Cancer - MercyOne Cancer Center
Waukee, Iowa, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Baylor Scott & White Health
Temple, Texas, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Texas Oncology- Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Epworth Hospital
East Melbourne, Victoria, Australia
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, Canada
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, Canada
CHU de Grenoble
La Tronche, , France
Chu de Montpellier-St Eloi
Montpellier, , France
CHU de Bordeaux
Pessac, , France
CHU DE RENNES - CHU Pontchaillou
Rennes, , France
Chu De Tours
Tours, , France
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, , Germany
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Otto von Guericke Uni Magdeburg Uniklinik
Magdeburg, , Germany
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli, Campania, Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Reference Study ID Number: GO45434 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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GO45434
Identifier Type: -
Identifier Source: org_study_id