Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than once drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: This randomized phase II/III trial is studying the side effects of giving clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see how well it works in treating young patients with T-cell acute lymphoblastic leukemia or precursor B-cell acute lymphoblastic leukemia.
Timeline
- Start
- 2010-10
- Primary completion
- 2019-12
- Completion
- 2024-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clofarabine | Other / unclassified | 40 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 2.5 g | Intravenous |
| Comparator | Cytarabine | Small molecule | 3 g | Intravenous |
| Comparator | Daunorubicin | Small molecule | 36 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Comparator | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Dexamethasone | Small molecule | — | Oral |
| Comparator | Etoposide | Small molecule | — | Intravenous |
| Comparator | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Comparator | Methotrexate | Small molecule | — | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | — | Intravenous |
| Comparator | Thioguanine | Small molecule | — | Oral |
| Comparator | Vincristine | Small molecule | — | Intravenous |
| Comparator | amsacrine | Small molecule | — | Intravenous |