Treatment of Older Adults With Acute Lymphoblastic Leukemia
Summary
The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib.
Timeline
- Start
- 2009-08
- Primary completion
- 2014-12
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intrathecal |
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Imatinib | Small molecule | — | Oral |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Subject | Methotrexate | Small molecule | — | Intrathecal |
| Subject | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Subject | Prednisone | Other / unclassified | — | Oral |
| Subject | Vincristine | Small molecule | — | Intravenous |