NCT00526305

LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Vincristine	1,5 mg/m2 i.v., days 1 and 8
DRUG	Daunorubicin	60 mg/m2, i.v., days 1 and 8
DRUG	Prednisone	60 mg/m2 day, i.v. or oral, days 1 to 14
DRUG	L-Asparaginase	10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
DRUG	Mitoxantrone	12 mg/m2 i.v days 15, 16 and 17
DRUG	Cytosine Arabinoside	1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
DRUG	Hydrocortisone	10 mg ,15 mg or 20 mg depending of age
DRUG	Mercaptopurine	50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
DRUG	Cyclophosphamide	600 mg/m2 day, i.v., days 1 to 15 in consolidation
DRUG	Dexamethasone	10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

Timeline

• Start date: 2000-01-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2007-09-10
• Last updated: 2010-01-05

Locations

50 sites across 1 country: Spain