Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261612
Status:
UNKNOWN
Last Update Posted:
2006-10-18
First Post:
2005-12-01
Brief Title:
Bortezomib Rituximab and Dexamethasone BORID for RelapsedRefractory Mantle Cell Lymphoma
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Mantle cell lymphoma MCL remains difficult to treat by standard treatment approaches Novel drugs have shown promising results in early clinical evaluations In the current trial we investigate a combination of bortezomib a proteasome inhibitor rituximab a monoclonal antibody and dexamethasone in patients with MCL who have already been pretreated by standard chemotherapy and show again signs of disease progression The study objectives include remission rates safety of this drug combination and survival time
Detailed Description:
Description of the treatment regimen Bortezomib 13 mgm2 as iv bolus injection given on days 1 4 8 and 11 of each treatment cycle Rituximab 375 mgm2 infusion day 1 of each cycle Dexamethasone 40 mg per day orally days 1 - 4 of each treatment cycle Treatment will be given for a total of 6 cycles every 21 days followed by maintenance treatment with rituximab 375 mgm2 every two months for 4 times
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 |
|---|---|---|---|
| MCL 03 | None | None | None |