Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408278
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2006-12-05
Brief Title:
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia PETHEMA LPA 2005
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia PETHEMA LPA 2005 Remission Induction With ATRA Idarubicin Risk-adapted Consolidation With ATRA and Anthracycline-based Chemotherapy IdarubicinMitoxantrone With Addition of Ara-C for High-risk Patients Maintenance Therapy With ATRA Low Dose Chemotherapy Methotrexate Mercaptopurine
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Primary objectives
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL
To evaluate the impact of mitoxantrone reduction on the event-free disease-free and overall survival as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL
To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients administered as in the original GIMEMA protocols on the event-free disease-free and overall survival as well as on the duration of remission and cumulative incidence of relapse
To evaluate the toxicity of the induction consolidation and maintenance chemotherapy in the whole series and in each treatment group in patients with APL
Secondary objectives
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL
To evaluate the impact of mitoxantrone reduction on the event-free disease-free and overall survival as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL
To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients administered as in the original GIMEMA protocols on the event-free disease-free and overall survival as well as on the duration of remission and cumulative incidence of relapse
To evaluate the toxicity of the induction consolidation and maintenance chemotherapy in the whole series and in each treatment group in patients with APL
Secondary objectives
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol
Detailed Description:
Treatment of induction with the simultaneous administration of ATRA 45 mgm2 day until the RC and idarubicine 12 mgm2 days 2 4 6 and 8 3 monthly cycles of consolidation with ATRA 45 mgm2 days 1-15 and idarubicine 5 mgm2 days 1-4 in the cycle 1 mitoxantrone 10 mgm2 days 1-3 in the cycle 2 and idarubicine 12 mgm2 day 1 in the cycle 3 The consolidation was reinforced for the group of patients with intermediate risk by means of an increase of the idarubicine to 7 mg in the cycle 1 and to 2 days in the cycle 3 In the patients of high risk the consolidation was reinforced with the addition of altar-c in the cycles 1 and 3 For the maintenance treatment one will administer to intermittent ATRA 15 days every 3 months and chemotherapy low doses with methotrexate and 6-mercaptopurina during two years
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