Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136565
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2005-08-26
Brief Title:
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
A Phase II Study Evaluating the Efficacy and Safety of Bortezomib Velcade Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-08
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:
None
Brief Summary:
The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade bortezomib with a standard chemotherapy regimen ACVBP doxorubicin cyclophosphamide vindesine bleomycin and prednisone in the treatment of previously untreated patients with peripheral T-cell lymphoma PTCL
Detailed Description:
This is a multicentric open-label non-randomized non-competitive clinical study evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients aged from 18 to 65 years with peripheral T-lymphoma
It is anticipated that 60 subjects will be enrolled over two years from June 2005 to May 2007
The duration of the treatment period is approximately 28 weeks and patients are followed until death
The total duration of the study is expected to be 5 years from June 2005 to May 2010
It is anticipated that 60 subjects will be enrolled over two years from June 2005 to May 2007
The duration of the treatment period is approximately 28 weeks and patients are followed until death
The total duration of the study is expected to be 5 years from June 2005 to May 2010
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 |
|---|---|---|---|
| Eudract 2005-001563-66 | None | None | None |
| Janssen i061-341-03 | None | None | None |