Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT03057418
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
Sponsor:
Biointegrator LLC
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: