drugset / Trial / NCT01319981

Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

NCT01319981

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma cells. This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only. Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.

Timeline

Start
2013-03-05
Primary completion
2020-11-11
Completion
2020-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Subject Cytarabine Small molecule 3 g Intravenous
Subject Dexamethasone Small molecule 40 mg Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Imatinib Small molecule 600 mg Oral
Subject Methotrexate Small molecule 800 mg/m2 Intravenous
Subject Methylprednisolone Other / unclassified 40 mg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject VSLI Unknown 2 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 600 mg/m2 Intravenous
Background G-CSF Unknown 10 ug/kg Subcutaneous
Background Pegfilgrastim Protein / enzyme biologic 6 mg/kg

Indications