LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
5 years
No
Ribera Josep Mª, Dr
Study Chair
HOSPITAL GERMANS TRIAS I PUJOL
Spain: Ministry of Health
LAL-Ph-2000
NCT00526305
January 2000
April 2005
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