drugset / Trial / NCT01670084
Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
NaSingle-groupOpen-labelTreatment
Summary
In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation \[CD\]20 positive disease). Researchers don't know all the ways that this drug may affect people
Timeline
- Start
- 2012-12
- Primary completion
- 2015-09
- Completion
- 2017-09
Outcome
Outcome not reported
Stopped (Enrollment): “No Accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nilotinib | Small molecule | — | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |