Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400478
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2006-11-16
Brief Title:
A Multicentre Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma NHL-13
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
Official Title:
A Multicentre Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma NHL-13
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This is a randomized open label phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL
Patients will be screened after successful standard induction therapy CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy 4-8 cycles Patients will be followed until an event occurs as defined in the protocol To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy measured by event-free survival EFS 440 patients with DLCBL or follicular NHL grade 3 220 per arm will be recruited
Patients will be screened after successful standard induction therapy CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy 4-8 cycles Patients will be followed until an event occurs as defined in the protocol To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy measured by event-free survival EFS 440 patients with DLCBL or follicular NHL grade 3 220 per arm will be recruited
Detailed Description:
None
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