Glofitamab
DrugParticipants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
NCT Number: NCT04980222
This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Aarhus Universitetshospital Skejby, Aarhus N, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional Inclusion Criterion for ctDNA High-Risk Participants:
Exclusion criteria
Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.
Time frame: Up to approximately 24 months
Time frame: Up to approximately 24 months
Time frame: Up to approximately 24 months
Time frame: Up to approximately 24 months
Time frame: Up to 90 days after the final dose of study treatment
Time frame: At pre-defined intervals up to approximately 10 months
Time frame: At pre-defined intervals up to approximately 10 months
Time frame: At pre-defined intervals up to approximately 10 months
Hoffmann-La Roche
Industry
A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse 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.
NCT03696784
Chemically-Induced Disorders, Cytokine Release Syndrome
Chapel Hill, North Carolina, United States
View Trial DetailsNCT02465060
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT00352924
Blood Protein Disorders, Cardiovascular Diseases
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT05346809
Blood Protein Disorders, Cardiovascular Diseases
Detroit, Michigan, United States
View Trial Details