drugset / Trial / NCT00526305

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

NCT00526305

Phase 4 Completed 100 enrolled PETHEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-01
Primary completion
2005-04
Completion
2005-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Cytarabine Small molecule 1500 mg/m2 Intravenous
Subject Cytarabine Small molecule 3000 mg/m2 Intravenous
Subject Daunorubicin Small molecule 60 mg/m2 Intravenous
Subject Dexamethasone Small molecule 10 mg/m2 Oral
Subject Hydrocortisone Other / unclassified 10 mg Intrathecal
Subject Hydrocortisone Other / unclassified 15 mg Intrathecal
Subject Hydrocortisone Other / unclassified 20 mg Intrathecal
Subject MERCAPTOPURINE ANHYDROUS Small molecule 50 mg/m2 Oral
Subject Mitoxantrone Small molecule 12 mg/m2 Intravenous
Subject Prednisone Other / unclassified 60 mg/m2 Intravenous
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Subject asparaginase Protein / enzyme biologic 10000 unknown Intravenous