drugset
drugset / Trial / NCT00476190

ALL Adult Consortium Trial: Adult ALL Trial

NCT00476190 ↗

Phase 2 Completed 112 enrolled Dana-Farber Cancer Institute Boston Children's Hospital · collabMassachusetts General Hospital · collabNCIC Clinical Trials Group · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL\>

Timeline

Start
2007-04
Primary completion
2013-09
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Cytarabine Small molecule — Intrathecal
Subject Dexamethasone Small molecule — Oral
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Hydrocortisone Other / unclassified — Intrathecal
Subject Imatinib Small molecule — —
Subject MERCAPTOPURINE ANHYDROUS Small molecule — Oral
Subject Methotrexate Small molecule — Intravenous
Subject Methylprednisone Unknown — Intravenous
Subject Pegaspargase Protein / enzyme biologic 2000 iu/kg Intravenous
Subject Pegaspargase Protein / enzyme biologic 2500 iu/kg Intravenous
Subject Vincristine Small molecule — Intravenous
Subject asparaginase Protein / enzyme biologic — Intramuscular

Indications

acute lymphoblastic leukemia