drugset / Trial / NCT03057418
Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |