Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494897
Status:
COMPLETED
Last Update Posted:
2009-05-19
First Post:
2007-06-29
Brief Title:
PETHEMA LAL-RI96 Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
PETHEMA LAL-RI96 Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2009-05
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:
The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission with an intensive consolidation follow by re-inductions
Detailed Description:
Induction therapy
Patients with standard risk receive vincristine 15 mgm2IV on days 1 8 15 and 22daunorubicin 30 mgm2IV on days 1 8 15 and 22 oral or IV prednisone 60 mgm2day days 1 to 27 and 30 mgm2day days 28 to 35asparaginase 10000 UIm2 IM or IV days 10 to 12 17 to 19 and 24 to 26cyclophosphamide 500 mgm2IV days 1 2 and 29 methotrexate cytosine arabinoside and hydrocortisone days 1 to 22
Patients older than 55 years are not treated with asparaginase and cyclophosphamide
Consolidation therapy 1
Standard risk Mercaptopurine 50 mgm2 PO days 1 to 7 28-35 and 56-63 methotrexate 3gm2IV24 hours day 1 28 and 56 VM-26 150 mgm212 hours IV days 14 and 42 ARA-C 500 mgm212 hours IV days 14-15 and 42-43 intrathecally treatment days 1 28 and 56
Patients over 50 years Mercaptopurine 50 mgm2 PO days 1 to 7 28-35 and 56-63methotrexate 15 gm2 IV24 hours day 1 28 and 56 VM-26 150 mgm212 hours IV days 14 and 42 ARA-C 500 mgm212 hours IV days 14-15 and 42-43 intrathecally treatment days 1 28 and 56
Consolidation therapy 2Reinduction one cycle similar to induction It starts one week after last dose of mercaptopurineDexamethasone 10 mgm2dayPO or IV days 1-14 and 5 mgm2day PO or IV days 15-21 VCR 15 mgm2 IV days 1 8 and 15 Daunorubicin 30 mgm2 IV days 1 2 8 and 9 cyclophosphamide 600 mgm2day IV days 1 and 15 Asparaginase 10000 UIm2 IM or IV days 1-3 and 15-17intrathecally treatment days 1 and 15
Maintenance therapy 1administration of continuous chemotherapy mercaptopurine and methotrexate and reinductions until one year from diagnosis
Continuous chemotherapy
MP 50 mgm2day PO
MTX 20 mgm2week IM
Reinductions
VCR 15 mgm2 IV day 1
PDN 60 mgm2day IV or PO days 1 to 7
L-ASA 20000 UIm2 IM or IV day 1
Intrathecally day 1
Seven cycles weeks 25 29 33 37 41 45 and 49
Maintenance therapy 2administration of continuous chemotherapy mercaptopurine and methotrexate while second year from diagnosis weeks 53 to 104
MP 50 mgm2day PO
MTX 20 mgm2week IM
Patients with standard risk receive vincristine 15 mgm2IV on days 1 8 15 and 22daunorubicin 30 mgm2IV on days 1 8 15 and 22 oral or IV prednisone 60 mgm2day days 1 to 27 and 30 mgm2day days 28 to 35asparaginase 10000 UIm2 IM or IV days 10 to 12 17 to 19 and 24 to 26cyclophosphamide 500 mgm2IV days 1 2 and 29 methotrexate cytosine arabinoside and hydrocortisone days 1 to 22
Patients older than 55 years are not treated with asparaginase and cyclophosphamide
Consolidation therapy 1
Standard risk Mercaptopurine 50 mgm2 PO days 1 to 7 28-35 and 56-63 methotrexate 3gm2IV24 hours day 1 28 and 56 VM-26 150 mgm212 hours IV days 14 and 42 ARA-C 500 mgm212 hours IV days 14-15 and 42-43 intrathecally treatment days 1 28 and 56
Patients over 50 years Mercaptopurine 50 mgm2 PO days 1 to 7 28-35 and 56-63methotrexate 15 gm2 IV24 hours day 1 28 and 56 VM-26 150 mgm212 hours IV days 14 and 42 ARA-C 500 mgm212 hours IV days 14-15 and 42-43 intrathecally treatment days 1 28 and 56
Consolidation therapy 2Reinduction one cycle similar to induction It starts one week after last dose of mercaptopurineDexamethasone 10 mgm2dayPO or IV days 1-14 and 5 mgm2day PO or IV days 15-21 VCR 15 mgm2 IV days 1 8 and 15 Daunorubicin 30 mgm2 IV days 1 2 8 and 9 cyclophosphamide 600 mgm2day IV days 1 and 15 Asparaginase 10000 UIm2 IM or IV days 1-3 and 15-17intrathecally treatment days 1 and 15
Maintenance therapy 1administration of continuous chemotherapy mercaptopurine and methotrexate and reinductions until one year from diagnosis
Continuous chemotherapy
MP 50 mgm2day PO
MTX 20 mgm2week IM
Reinductions
VCR 15 mgm2 IV day 1
PDN 60 mgm2day IV or PO days 1 to 7
L-ASA 20000 UIm2 IM or IV day 1
Intrathecally day 1
Seven cycles weeks 25 29 33 37 41 45 and 49
Maintenance therapy 2administration of continuous chemotherapy mercaptopurine and methotrexate while second year from diagnosis weeks 53 to 104
MP 50 mgm2day PO
MTX 20 mgm2week IM
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