drugset / Trial / NCT00853008

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

NCT00853008

Phase 4 Completed 100 enrolled PETHEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

Timeline

Start
2003-01
Primary completion
2012-11
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP Unknown 25000 iu Intravenous
Subject Cytarabine Small molecule 30 mg Intravenous
Subject Cytarabine Small molecule 2000 mg/m2 Intravenous
Subject Daunorubicin Small molecule 60 mg/m2 Intravenous
Subject Dexamethasone Small molecule 5 mg/m2 Intravenous
Subject Hydrocortisone Other / unclassified 20 mg Intrathecal
Subject MERCAPTOPURINE ANHYDROUS Small molecule 100 mg/m2 Oral
Subject Methotrexate Small molecule 15 mg Intravenous
Subject Mitoxantrone Small molecule 12 mg/m2 Intravenous
Subject Prednisone Other / unclassified 60 mg/m2 Intravenous
Subject Teniposide Small molecule 150 mg/m2 Intravenous
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous