Glofitamab
DrugParticipants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.
Other names: RO7082859
NCT Number: NCT04313608
This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Prince of Wales Hospital; Haematology, Randwick, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.
Other names: RO7082859
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.
Other names: RO7030816
Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.
Other names: RO5072759
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Other names: RO4877533
Time frame: Baseline - 90 days after last dose of study treatment
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline - 90 days after last dose of study treatment
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline - 90 days after last dose of study treatment
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline - 90 days after last dose of study treatment
Severity of CRS was determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria, in which Grade 1 as fever (≥38.0°C) with or without other symptoms; Grade 2 as fever with hypotension not requiring vasopressors and/or hypoxia requiring the use of oxygen (low-flow); and Grade 3 as fever with hypotension requiring one vasopressor with or without vasopressin and/or hypoxia requiring the use of oxygen (high-flow).
Time frame: Up to approximately 16 months
Time frame: Up to approximately 16 months
Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), with higher scores indicating more extensive disease.
Time frame: Up to approximately 16 months
Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), while a PR = partial metabolic response with a score of 4 or 5 on 5PS with higher scores indicating more extensive disease.
Time frame: Cycle 1 Day 8 and Cycle 2 Day 1
Hoffmann-La Roche
Industry
A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05024045
B-cell Lymphoma, Blood Protein Disorders
Tucson, Arizona, United States
View Trial DetailsNCT05653271
B-cell Lymphoma, Burkitt Lymphoma
Orlando, Florida, United States
View Trial DetailsNCT03740529
B-cell Lymphoma, Blood Protein Disorders
Scottsdale, Arizona, United States
View Trial DetailsNCT03424122
B-cell Lymphoma, Hemic and Lymphatic Diseases
Tucson, Arizona, United States
View Trial Details