drugset
drugset / Trial / NCT00671658

Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

NCT00671658 ↗

Phase 2 Completed 220 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

Timeline

Start
2002-11
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 300 mg/m2 —
Subject Cytarabine Small molecule 100 mg Intrathecal
Subject Cytarabine Small molecule 3000 mg/m2 Intrathecal
Subject Dexamethasone Small molecule 40 mg Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 —
Subject Methotrexate Small molecule 6 mg Intrathecal
Subject Methotrexate Small molecule 12 mg Intrathecal
Subject Methotrexate Small molecule 200 mg/m2 Intrathecal
Subject Methotrexate Small molecule 800 mg/m2 Intrathecal
Subject Methylprednisolone Other / unclassified 40 mg Intravenous
Subject Pegylated asparaginase Unknown 2000 iu —
Subject Rituximab Monoclonal antibody 375 mg/m2 —
Subject Vincristine Small molecule 2 mg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 600 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications

acute lymphoblastic leukemia