Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410163
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2006-12-11
Brief Title:
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-labeled Randomized Two-dose Parallel Group Trial of Ofatumumab a Fully Human Monoclonal Anti-CD20 Antibody in Combination With Fludarabine and Cyclophosphamide in Patients With Previously Untreated B-cell CLL
Status:
COMPLETED
Status Verified Date:
2013-11
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:
BIFROST
Brief Summary:
To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Hx-CD20-407 | OTHER | None | None |
| The BIFROST trial | Other Identifier | Genmab | None |