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

Acute Lymphoblastic Leukemia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT00526305
• Study type: Interventional
• Source: PETHEMA Foundation
• Status: Completed
• Phase: Phase 4
• Start date: January 2000
• Completion date: April 2005