Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136552
Status:
COMPLETED
Last Update Posted:
2007-07-03
First Post:
2005-08-25
Brief Title:
Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
Status:
COMPLETED
Status Verified Date:
2007-07
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:
None
Brief Summary:
The purpose of this study is to assess in a prospective multicentric study Phase III the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma
Detailed Description:
Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either
Arm A CHVP alpha2a-interferon Patients will receive 12 courses of CHVP cyclophosphamide 600 mgm² adriamycin 25 mgm² etoposide 100 mgm² on day 1 and prednisolone 40 mgm² for 5 days one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 45 millions units sub-cutaneously three times a week for 18 months
Arm B CHVP alpha2a-interferon rituximab Patients will receive 6 monthly courses of CHVP cyclophosphamide 600 mgm² adriamycin 25 mgm² etoposide 100 mgm² on day 1 and prednisolone 40 mgm² for 5 days associated with 6 infusions of rituximab 375 mgm2 associated with alpha2a-interferon 45 millions units sub-cutaneously three times a week for 18 months
Arm A CHVP alpha2a-interferon Patients will receive 12 courses of CHVP cyclophosphamide 600 mgm² adriamycin 25 mgm² etoposide 100 mgm² on day 1 and prednisolone 40 mgm² for 5 days one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 45 millions units sub-cutaneously three times a week for 18 months
Arm B CHVP alpha2a-interferon rituximab Patients will receive 6 monthly courses of CHVP cyclophosphamide 600 mgm² adriamycin 25 mgm² etoposide 100 mgm² on day 1 and prednisolone 40 mgm² for 5 days associated with 6 infusions of rituximab 375 mgm2 associated with alpha2a-interferon 45 millions units sub-cutaneously three times a week for 18 months
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 |
|---|---|---|---|
| PHRC | None | None | None |