Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00526305
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2007-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Sponsor:
PETHEMA Foundation
Organization:
Study Overview
Official Title:
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
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:
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Detailed Description:
Remission Induction:
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
1\. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
* Dexamethasone (DXM):
* 10 mg/m2 day, p.o. or i.v. days 1-14
* 5 mg/m2 day, p.o. or i.v., days 15-21
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
* CFM 600 mg/m2 day, i.v., days 1 and 15
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
* Intrathecal treatment days 1 and 15.
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
1\. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
* Dexamethasone (DXM):
* 10 mg/m2 day, p.o. or i.v. days 1-14
* 5 mg/m2 day, p.o. or i.v., days 15-21
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
* CFM 600 mg/m2 day, i.v., days 1 and 15
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
* Intrathecal treatment days 1 and 15.
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
Study Oversight
Has Oversight DMC:
True
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?: