NCT03456466

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

A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	TQB2303	375mg/m2 ，iv
DRUG	Rituximab	375mg/m2 ，iv

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2018-03-07
• Last updated: 2018-03-07

Locations

2 sites across 1 country: China