Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |