NCT01534949

Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial

A Phase 1, Multicenter, Open-Label, Single-Arm Study to Evaluate the Initial Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CT-P10 Given in Combination With Dexamethasone, Cytosine Arabinoside, and Cisplatin (DHAP) in Patients With Diffuse Large B-Cell Lymphoma as Second-Line Chemotherapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	375 mg/m2 by intravenous \[IV\] infusion

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-02-17
• Last updated: 2014-07-23

Locations

1 site across 1 country: South Korea