Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475280
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2007-05-17
Brief Title:
Geriatric Assessment Adapted Therapy for Ph- ALL Elderly Patients
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
Geriatric Assessment Adapted Therapy for Ph- ALL Elderly Patients GIMEMA Protocol LAL1104 EudraCT Code 2005-002156-17
Status:
COMPLETED
Status Verified Date:
2022-10
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:
LAL1104
Brief Summary:
This study aims at considering clinical heterogeneity of patients based on a geriatric assessment without taking into account the real age of the subject This will allow physicians to adapt therapy according to three different groups of patients frail fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients
Detailed Description:
Treatment
1 Frail patients
Pretreatment with PDN
Induction with Vinblastine and PDN
Maintenance with MTX 6-MP VBL and PDN
2 Fit patients
Pretreatment with PDN
Induction with VCR DNR and PDN
Consolidation with MTX ARA-C and G-CSF
Autologous transplantation
Maintenance with MTX 6-MP VCR and PDN
3 Intermediate patients
Pretreatment with PDN
Induction with VCR DNR and PDN
Consolidation with MTX ARA-C and G-CSF
A second cycle of consolidation therapy
Maintenance with MTX 6-MP VCR and PDN
1 Frail patients
Pretreatment with PDN
Induction with Vinblastine and PDN
Maintenance with MTX 6-MP VBL and PDN
2 Fit patients
Pretreatment with PDN
Induction with VCR DNR and PDN
Consolidation with MTX ARA-C and G-CSF
Autologous transplantation
Maintenance with MTX 6-MP VCR and PDN
3 Intermediate patients
Pretreatment with PDN
Induction with VCR DNR and PDN
Consolidation with MTX ARA-C and G-CSF
A second cycle of consolidation therapy
Maintenance with MTX 6-MP VCR and PDN
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