Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00535912
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2007-09-26
Brief Title:
Phase III Study Treatment of CLL B and C
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
A Multicentric Phase III Study in Patients With CLL B and C 60 Years Not Treated 6 Montly CHOP 6 CHOP Every 3 Months Versus 3 Montly CHOP Intensification and Autograft
Status:
COMPLETED
Status Verified Date:
2007-09
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:
GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies Conventional chemotherapy consisted of six monthly courses of CHOP followed by 6 CHOP courses every other 3 months in case of response Experimental arm consisted of high dose therapy with autologous CD34 purified progenitor cell support used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response
Detailed Description:
The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than 60 years old Conventional chemotherapy Arm A consisted of six monthly courses of CHOP ie vincristin IV 1 mgm2 on day 1 doxorubicin IV 25 mgm2 on day 1 cyclophosphamide Cy 300 mgm2 and prednisone 40 mgm2 both given orally from day 1 to day 5 followed by 6 CHOP courses every other 3 months in case of response Fludarabine 25 mgm2 d IV for 5 consecutive days was used in case of non response stable disease or progression after 3 CHOP courses This conventional therapy was compared to high dose therapy with autologous CD34 purified progenitor cell support Arm B used as consolidation of Complete Remission CR or Very Good Partial Response VGPR defined by 50 tumoral response and bone marrow lymphocyte infiltration 30 obtained after 3 monthly courses of CHOP In the absence of CR or VGPR 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4 gm2 G-CSF administration The conditioning regimen included TBI 12 Gy and Cy 60 mg kg d for 2 days
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