drugset / Trial / NCT00372619
Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, 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 one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
Timeline
- Start
- 2007-03
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 52 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 30 mg | Intravenous |
| Background | Cytarabine | Small molecule | 50 mg | Intravenous |
| Background | Cytarabine | Small molecule | 70 mg | Intravenous |
| Background | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 8 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 10 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 12 mg | Intrathecal |