Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464217
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2007-04-20
Brief Title:
Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
PETHEMA-LAM99Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Status:
COMPLETED
Status Verified Date:
2010-01
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:
To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol decreasing the dose of Idarubicin to try to reduce the deaths in induction
Detailed Description:
INDUCTION TREATMENT Ara-C 100 mgm 2 day in continuous perfusiondays 1 - 7 Idarubicin 8 mgm 2 day days 1 - 3 in bolus GM-CSF Leucomax 5 mcgkg subcutaneous or endovenous from day 4 after finishing the chemotherapy until the recovery of neutropenia 1000mm 3
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle will receive a second cycle to consolidation The patients who do not reach a complete response with the first cycle will receive a second cycle If after two cyclesdo not obtain the response patient should leave the protocol
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation or after two cycles of induction will receive a treatment of intensification with ARA-C 500 mgm 2 12 h in one hour infusion days 1-4 Daunomycin 45 mgm 2 day bolu days 5-7 GM-CSF Leucomax 5 mcgkg from day to 4 after finishing the chemotherapy until the recovery of neutropenia 1000mm 3
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle will receive a second cycle to consolidation The patients who do not reach a complete response with the first cycle will receive a second cycle If after two cyclesdo not obtain the response patient should leave the protocol
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation or after two cycles of induction will receive a treatment of intensification with ARA-C 500 mgm 2 12 h in one hour infusion days 1-4 Daunomycin 45 mgm 2 day bolu days 5-7 GM-CSF Leucomax 5 mcgkg from day to 4 after finishing the chemotherapy until the recovery of neutropenia 1000mm 3
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