Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-31 @ 2:15 PM
Study NCT ID:
NCT00261612
Status:
UNKNOWN
Last Update Posted:
2006-10-18
First Post:
2005-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma
Sponsor:
Medical University of Vienna
Organization:
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: 1.3 mg/m2 as i.v. bolus injection, given on days 1, 4, 8, and 11 of each treatment cycle; Rituximab: 375 mg/m2 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 mg/m2 every two months for 4 times)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MCL 03 | None | None | View |