Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285389
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2006-01-31
Brief Title:
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Phase II study to test in first line the VAD Vincristine Adriablastine Dexamethasone C Chlorambucil regimen associated to rituximab R-VAD C in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of R VAD C regimen
Detailed Description:
All patients at diagnosis with a stage II III or IV an arbor disease are treated with 4 cycles of R VAD C
The responders more than RP 50 received 2 other cycles before to be intensified with alkeran 140 mg m2 and a 8 grays TBI over 4 days before an autologous PBSCTThe stem cell collection is realised after a mobilisation with HD Cyclophosphamide 4 mgm2 after the four R-VAD C cycles and purged by a rituximab injection 10 days before the collection
There is an clinical and molecular evaluation of the strategy
The responders more than RP 50 received 2 other cycles before to be intensified with alkeran 140 mg m2 and a 8 grays TBI over 4 days before an autologous PBSCTThe stem cell collection is realised after a mobilisation with HD Cyclophosphamide 4 mgm2 after the four R-VAD C cycles and purged by a rituximab injection 10 days before the collection
There is an clinical and molecular evaluation of the strategy
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