drugset
drugset / Trial / NCT00186875

Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT00186875 ↗

Phase 2 Completed 47 enrolled St. Jude Children's Research Hospital
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are. Primary Objectives: * To estimate the response rate for patients with refractory or relapsed ALL. * To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.

Timeline

Start
2003-11
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic — —
Subject Cyclophosphamide Other / unclassified 300 mg/m2 —
Subject Cytarabine Small molecule 25 mg/m2 Intravenous
Subject Cytarabine Small molecule 300 mg/m2 Intravenous
Subject Cytarabine Small molecule 1 g Intravenous
Subject Dexamethasone Small molecule 5 mg/m2 Oral
Subject Dexamethasone Small molecule 6 mg/m2 Oral
Subject Dexamethasone Small molecule 8 mg/m2 Oral
Subject Dexamethasone Small molecule 12 mg/m2 Oral
Subject Etoposide Small molecule 25 mg/m2 Intravenous
Subject Etoposide Small molecule 300 mg/m2 Intravenous
Subject MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2 —
Subject Methotrexate Small molecule 40 mg/m2 Intravenous
Subject Methotrexate Small molecule 8 g Intravenous
Subject Mitoxantrone Small molecule 12 mg/m2 —
Subject Pegaspargase Protein / enzyme biologic 2500 unknown Intramuscular
Subject Teniposide Small molecule 150 mg/m2 Intravenous
Subject Teniposide Small molecule 165 mg/m2 Intravenous
Subject Vinblastine Small molecule 6 mg/m2 —
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Subject Vincristine Small molecule 2 mg/m2 Intravenous
Subject asparaginase Protein / enzyme biologic — —

Indications

acute lymphoblastic leukemia lymphoblastic lymphoma