drugset / Trial / NCT03057418

Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim

NCT03057418 ↗

Phase 1 Completed 7 enrolled Biointegrator LLC
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade. The study will be carried out in 4-6 Russian and Belarussian sites. The study will be consisted of screening period, induction (obligatory) phase and supporting (non-obligatory) phase of the investigational therapy and post-treatment follow-up period.

Timeline

Start
2013-06
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aurixim Unknown 125 mg/m2 Intravenous
Subject Aurixim Unknown 250 mg/m2 Intravenous
Subject Aurixim Unknown 375 mg/m2 Intravenous
Subject Aurixim Unknown 500 mg/m2 Intravenous

Indications