Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169169
Status:
TERMINATED
Last Update Posted:
2005-09-15
First Post:
2005-09-13
Brief Title:
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant ASCT
Status:
TERMINATED
Status Verified Date:
2005-09
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:
Rituximab vs observation after high-dose consolidative first-line chemotherapy HDC with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma
Detailed Description:
This is a multicentric open-label randomized clinical study evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk aa-IPI 2 or 3 Diffuse Large B-Cell Lymphoma
The duration of the treatment period is approximately 25 weeks and patients are followed until Death
From 1099 to 0503 476 patients were enrolled 235 patients were assigned to receive ACE and 241 to ACVBP Among the 331 patients in Complete response CRCRu after induction who received HDC 269 were randomized R2 after hematological recovery to receive either rituximab n139 or nothing n130
The final analysis was performed in June 2005
The duration of the treatment period is approximately 25 weeks and patients are followed until Death
From 1099 to 0503 476 patients were enrolled 235 patients were assigned to receive ACE and 241 to ACVBP Among the 331 patients in Complete response CRCRu after induction who received HDC 269 were randomized R2 after hematological recovery to receive either rituximab n139 or nothing n130
The final analysis was performed in June 2005
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