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

Conditions

Diffuse Large B-Cell Lymphoma

Brief summary

1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma

Detailed description

1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria, 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first, 3. OS, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events, 6. Serum concentrations of glofitamab at specified timepoints, 7. Serum trough concentrations of glofitamab at specified timepoints, 8. Maximum concentration (Cmax) of glofitamab at specified timepoints, 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints, 10. Relationship between ADA status and efficacy, safety, or PK endpoints

Related papers

No related papers found yet.

Interventions

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGGlofitamab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma	—

Secondary

Measure	Time frame
1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria, 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first, 3. OS, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events, 6. Serum concentrations of glofitamab at specified timepoints, 7. Serum trough concentrations of glofitamab at specified timepoints, 8. Maximum concentration (Cmax) of glofitamab at specified timepoints, 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints, 10. Relationship between ADA status and efficacy, safety, or PK endpoints	—

Measure

Time frame

1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria, 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first, 3. OS, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events, 6. Serum concentrations of glofitamab at specified timepoints, 7. Serum trough concentrations of glofitamab at specified timepoints, 8. Maximum concentration (Cmax) of glofitamab at specified timepoints, 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints, 10. Relationship between ADA status and efficacy, safety, or PK endpoints

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Countries

Denmark, France, Netherlands, Poland, Spain

Outcome results

None listed