Ignite Creation Date:
2025-12-18 @ 9:27 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT04073147
Status:
None
Last Update Posted:
2022-01-19 00:00:00
First Post:
2019-08-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma
Sponsor:
None
Organization:
Study Overview
Official Title:
Chemotherapy Free Treatment With Venetoclax and Obinutuzumab for Relapsed / Refractory Primary CNS Lymphoma Patients (VENOBI-CNS Study) - A Phase IB Study to Assess the Pharmacokinetics in the Cerebrospinal Fluid
Status:
None
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENOBI-CNS
Brief Summary:
This is a phase IB study investigating the pharmacokinetics of the combination venetoclax and obinutuzumab in the cerebrospinal fluid of patient with relapsed primary CNS lymphoma. Three dosing groups of venetoclax (600mg, 800mg, and 1000mg) are planned; dosing of obinutuzumab will be 1000mg for each dosing group. 15 patients are planned being included from two centers in Germany.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: