Glofitamab
DrugParticipants will receive intravenous (IV) glofitamab for up to 3 cycles.
NCT Number: NCT05364424
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Chao Family Comprehensive Cancer Center UCI, Orange, California, United States
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 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.
Time frame: Up to 2.5 years
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)
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)
Time frame: Up to 2.5 years
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: From enrollment to death from any cause (up to 2.5 years)
Time frame: Up to 2.5 years
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)
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)
Time frame: Up to 2.5 years
Time frame: Up to 2.5 years
Time frame: Up to 2.5 years
Time frame: Up to 2.5 years
Time frame: From baseline up to 2.5 years
Hoffmann-La Roche
Industry
A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse 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.
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