Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509379
Status:
COMPLETED
Last Update Posted:
2011-01-28
First Post:
2007-07-30
Brief Title:
Non-randomized Safety Study With BortezomibRituximab in RelapsedRefractory Indolent Lymphoma
Sponsor:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Organization:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Study Overview
Official Title:
A Phase II Multicenter Non-randomized Study to Assess Safety Toxicity and Clinical Activity of the Association of BortezomibVELCADEWith Rituximab in RelapsedRefractory Indolent Non Follicular and Mantle-cell Non-Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-07
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:
LYM-2023
Brief Summary:
The promising activity of Bortezomib as single agent in low grade lymphoma patients in small studies has led to a number of larger multicenter trials with Bortezomib in combination with Rituximab in mantle-cell lymphoma follicular lymphoma and marginal zone lymphoma
Detailed Description:
This is a open label non randomized phase II multicenter prospective trial to evaluate the efficacy and safety of the combination of bortezomib and rituximab in patients with relapsed or refractory rituximab naïve or sensitive indolent non-follicular and mantle cell non-Hodgkins lymphoma Despite of the availability of treatment for this disease this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed indolent lymphoma This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation
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 |
|---|---|---|---|
| LYM-2023 | None | None | None |