drugset / Trial / NCT03456466

Study of TQB2303 in Patients With Aggressive CD20 Positive Non-Hodgkin's Lymphoma

NCT03456466 ↗

Phase 1/2 Unknown 122 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Outcome Measures: Area under the curve (AUC) forTQB2303 and rituximab concentrations \[ Time Frame: 85 days \] Secondary Outcome Measures: The Maximum Concentration (Cmax) of the TQB2303 and rituximab \[ Time Frame: 85 days \] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).

Timeline

Start
2017-05-01
Primary completion
2018-06-30
Completion
2018-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject TQB2303 Unknown 375 mg/m2 Intravenous

Indications