drugset / Trial / NCT00968253
RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
Timeline
- Start
- 2009-11
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 600 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 3 g/kg | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 200 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 800 mg/m2 | Intravenous |
| Background | Methylprednisone | Unknown | 50 mg | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | Vincristine | Small molecule | 2 mg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |